FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, monitoring patients with concomitant use of medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, is recommended as they may have higher exposure.
Slovenian: Med uporabo zdravil, ki se presnavljajo s CYP2C8 (npr. repaglinid, paklitaksel, pioglitazon ali rosiglitazon), je izpostavljenost lahko večja, zato je bolnike, ki prejemajo takšna zdravila, priporočljivo kontrolirati.
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide Zentiva.
Slovenian: Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Leflunomid Zentiva je treba upoštevati dolg razpolovni čas leflunomida.
English: However, a 25% decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Slovenian: Toda med sočasno uporabo A771726 in varfarina se je največja vrednost internacionalnega normaliziranega razmerja (INR) v primerjavi z uporabo samega varfarina zmanjšala za 25 %.
English: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin)).
Slovenian: Najpogostejši neželeni učinki, o katerih poročajo in so povezani z leflunomidom, so: blago zvišanje krvnega tlaka, levkopenija, parestezija, glavobol, omotica, driska, navzea, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu, zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji), pruritus, suha koža, tendosinovitis, zvišan CPK, anoreksija, izguba telesne mase (ponavadi nepomembno), astenija, blage alergijske reakcije in zvišanje jetrnih parametrov (transaminaze (zlasti ALT), manj pogosto gama-GT, alkalne fosfataze, bilirubina).
English: Respiratory reactions
Slovenian: Reakcije dihal
English: Washout procedure
Slovenian: Postopek izpiranja
English: Leflunomide Zentiva contains lactose
Slovenian: Zdravilo Leflunomid Zentiva vsebuje laktozo
English: Skin and subcutaneous tissue disorders Common:
Slovenian: Bolezni kože in podkožja Pogosti:
English: Cases of peripheral neuropathy have been reported in patients receiving leflunomide.
Slovenian: Pri bolnikih, ki so jemali zdravilo Leflunomid Zentiva, so poročali o primerih periferne nevropatije.
English: Leflunomide Zentiva 20 mg film-coated tablets are yellowish to ochre and triangular.
Slovenian: Leflunomid Zentiva 20 mg filmsko obložene tablete so rumenkaste do okraste barve in trikotne oblike.
English: This is especially important if you are taking: - other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill)
Slovenian: da bi zmanjšali tveganje neželenih učinkov tega zdravila, - teriflunomid za multiplo sklerozo, - repaglinid, pioglitazon, nateglinid, ali rosiglitazon za sladkorno bolezen, - daunorubicin, doksorubicin, paklitaksel, ali topotekan za raka, - duloksetin za depresijo, inkontinenco urina ali bolezen ledvic pri sladkornih bolnikih, - alosetron za obvladovanje hude driske, - teofilin za astmo, - tizanidin, mišični relaksant, - peroralni kontraceptivi (vključno z etinilestradiolom and levonorgestrelom), - cefaklor, benzilpenicillin (penicillin G), ciprofloksacin za okužbe,
English: Colestyramine 8 g is administered 3 times daily.
Slovenian: Trikrat na dan se daje po 8 g holestiramina.
English: pulmonary hypertension Gastrointestinal disorders Common:
Slovenian: pljučna hipertenzija Bolezni prebavil Pogosti:
English: Luxembourg/Luxemburg
Slovenian: Luxembourg/Luxemburg Zentiva, k.s.
English: Methotrexate
Slovenian: Metotreksat
English: Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Slovenian: Pri bolnikih, zdravljenih z leflunomidom, so poročali o kolitisu, vključno z mikroskopskim kolitisom.
English: General disorders and administration site conditions Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti:
English: There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of
Slovenian: Po ponavljajočih se odmerkih A771726 se je povprečna Cmax etinilestradiola povečala za 1,58-krat in njegova povprečna AUC0-24 za 1,54-krat); povprečna Cmax levonorgestrela se je povečala za 1,33-krat in povprečna AUC0-24 za 1,41-krat).
English: - a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal, - severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Slovenian: Zelo redki neželeni učinki (prizadenejo lahko največ 1 od 10.000 bolnikov) izrazito zmanjšanje nekaterih belih krvnih celic (agranulocitoza), hude in potencialno hude alergijske reakcije, vnetje majhnih žil (vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom), vnetje trebušne slinavke (pankreatitis), resne poškodbe jeter, kot sta odpoved jeter ali nekroza, ki sta lahko usodni, hude, včasih življenje ogrožujoče reakcije (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila Leflunomid Zentiva, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: hypouricemia Psychiatric disorders Uncommon: anxiety Nervous system disorders Common:
Slovenian: hipourikemija Psihiatrične motnje Občasni:
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies
Slovenian: V preskušanjih III. faze je bil delež odziva po ACR na leflunomid 20 mg/dan v primerjavi s placebom 54,6 % proti 28,6 % (študija MN301) in 49,4 % proti 26,3 % (študija US301).
English: Metabolism and nutrition disorders Common:
Slovenian: Presnovne in prehranske motnje Pogosti:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BLISTER PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA /PRETISNI OMOT
English: Leflunomide Zentiva 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Leflunomid Zentiva 20 mg
English: The safety data obtained from both treatment groups were consistent with the known safety profile of leflunomide, however, the incidence of gastrointestinal adverse events and of elevated liver enzymes tended to be higher in the patients receiving the loading dose of 100 mg leflunomide.
Slovenian: Vendar pa je bila incidenca gastrointestinalnih neželenih učinkov in zvišanih jetrnih encimov nekoliko večja pri bolnikih, ki so prejeli začetni odmerek 100 mg leflunomida.
English: Each film-coated tablet contains 20 mg leflunomide.
Slovenian: Vsaka filmsko obložena tableta vsebuje 20 mg leflunomida.
English: There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of CYP2C8 in vivo.
Slovenian: Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax repaglinida za 1,7-krat in njegove povprečne AUC za 2,4-krat; to kaže, da A771726 in vivo zavira CYP2C8.
English: Management
Slovenian: Ukrepanje
English: - a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood.
Slovenian: Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov) zmanjšanje števila rdečih krvnih celic (anemija) in zmanjšanje števila krvnih ploščic (trombocitopenija), zmanjšanje koncentracije kalija v krvi, tesnobnost, motnje okusa, pojav koprivnice, pretrganje tetive, zvečanje koncentracije maščob v krvi (holesterola in trigliceridov), zmanjšanje koncentracije fosfata v krvi.
English: - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), talc (E553b), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating.
Slovenian: - Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), smukec (E553b), brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete, ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171) in makrogol 8000 v filmski oblogi.
English: 30 film-coated tablets 100 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 100 filmsko obloženih tablet
English: - a slight decrease in the number of white blood cells (leucopenia), - mild allergic reactions, - loss of appetite, weight loss (usually insignificant), - tiredness (asthenia), - headache, dizziness, - abnormal skin sensations like tingling (paraesthesia), - mild increase in blood pressure,
Slovenian: Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov) rahlo zmanjšanje števila belih krvnih celic (levkopenija), blage alergijske reakcije, izguba apetita, hujšanje (ponavadi nepomembno), utrujenost (astenija), glavobol, omotica, nenormalne kožne zaznave, npr. mravljinčenje (parestezije),
English: Each film-coated tablet contains 10 mg leflunomide.
Slovenian: Vsaka filmsko obložena tableta vsebuje 10 mg leflunomida.
English: - if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Slovenian: Ne jemljite zdravila Leflunomid Zentiva - če ste kdaj doživeli alergijsko reakcijo na leflunomid (zlasti resno kožno reakcijo, ki jo pogosto spremljajo povišana telesna temperatura, bolečine v sklepih, rdeči madeži na koži ali mehurji,
English: Leflunomide Zentiva 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Leflunomid Zentiva 10 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: A771726.
Slovenian: Zaradi zelo dolgega razpolovnega časa A771726
English: - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating.
Slovenian: - Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete, ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171) in makrogol 8000 v filmski oblogi.
English: Each film-coated tablet contains 100 mg leflunomide.
Slovenian: Vsaka filmsko obložena tableta vsebuje 100 mg leflunomida.
English: Leflunomide Zentiva 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Leflunomid Zentiva 100 mg
English: - colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain, - an increase in some liver test results, - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy).
Slovenian: - nenormalne kožne zaznave, npr. mravljinčenje (parestezije), - blago zvišanje krvnega tlaka, - kolitis, - driska, - slabost, bruhanje, - vnetje v ustih ali razjede v ustih, - bolečine v trebuhu, - zvišanje nekaterih vrednosti jetrnih testov, - zvečano izpadanje las, - ekcem, suha koža, izpuščaj, srbenje, - tendonitis (bolečina, običajno v rokah in nogah, ki jo povzroči vnetje membrane, ki obdaja tetive), - zvišanje določenih encimov v krvi (kreatin-fosfokinaza), - težave z živci rok ali nog (periferna nevropatija).
English: Hepatic impairment
Slovenian: pretrganje tetive
English: Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Slovenian: Leflunomid Zentiva 100 mg filmsko obložene tablete leflunomid
English: Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Slovenian: Leflunomid Zentiva 20 mg filmsko obložene tablete leflunomid
English: The following pharmacokinetic and pharmacodynamic interaction studies were conducted with A771726 (principal active metabolite of leflunomide).
Slovenian: Z A771726 (glavnim aktivnim presnovkom leflunomida) so opravili naslednje študije farmakokinetičnega in farmakodinamičnega medsebojnega delovanja.
English: Binding of A771726 appeared slightly reduced and more variable in plasma from patients with rheumatoid arthritis or chronic renal insufficiency.
Slovenian: V plazmi bolnikov z revmatoidnim artritisom ali kronično ledvično insuficienco je vezava A771726 rahlo zmanjšana in bolj variabilna.
English: Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Slovenian: Leflunomid Zentiva 10 mg filmsko obložene tablete leflunomid
English: Also contains lactose.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo.
English: A pharmacodynamics interaction with warfarin was observed with A771726 in a clinical pharmacology study (see below).
Slovenian: V klinični farmakološki študiji (glejte spodaj) so ugotovili farmakodinamično medsebojno delovanje varfarina in A771726.
English: There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726.
Slovenian: Po večkratnih odmerkih A771726 se je povprečna Cmax rosuvastatina povečala za 2,65-krat in njegova povprečna AUC za 2,51-krat.
English: One film-coated tablet contains 20 mg of leflunomide - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 and yellow ferric oxide (E172) in the film-coating.
Slovenian: - Pomožne snovi so: koruzni škrob, povidon (E1201), krospovidon (E1202), brezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) in laktoza monohidrat v jedru tablete, ter smukec (E553b), hipromeloza (E464), titanov dioksid (E171), makrogol 8000 in rumeni železov oksid (E172) v filmski oblogi.
English: 3 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 3 filmsko obložene tablete
English: Treatment withdrawal may be considered taking into account patient's disease and past history.
Slovenian: Glede na bolnikovo bolezen in njeno anamnezo je treba premisliti o prekinitvi zdravljenja z zdravilom.
English: - if you are male and wish to father a child. As it can not be excluded that Leflunomide Zentiva passes into semen, reliable contraception should be used during treatment with Leflunomide Zentiva.
Slovenian: Obstaja možnost, da se zdravilo Leflunomid Zentiva izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Leflunomid Zentiva uporablajti zanesljivo kontracepcijo.
English: INSTRUCTIONS ON USE 16.
Slovenian: - Navodilo shranite.
English: Leflunomide Zentiva 20 mg film-coated tablets
Slovenian: IME ZDRAVILA Leflunomid Zentiva 20 mg filmsko obložene tablete
English: Leflunomide Zentiva 100 mg film-coated tablets
Slovenian: IME ZDRAVILA Leflunomid Zentiva 100 mg filmsko obložene tablete
English: EU/1/09/604/010 3 tablets
Slovenian: EU/1/09/604/002 100 tablet
English: OTHER
Slovenian: Lot
English: EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets
Slovenian: EU/1/09/604/009 100 tablet
English: Renal impairment
Slovenian: Okvara jeter
English: Tablet core:
Slovenian: Navodilo vsebuje:
English: Leflunomide Zentiva 10 mg film-coated tablets
Slovenian: IME ZDRAVILA Leflunomid Zentiva 10 mg filmsko obložene tablete
English: Zentiva, a.s.
Slovenian: Slovenská republika Zentiva, a.s.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI NALEPKA NA PLASTENKI
English: EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets
Slovenian: EU/1/09/604/004 100 tablet
English: PV-Lithuania@zentiva.com
Slovenian: PV-Hungary@zentiva.com
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov) - zmanjšanje števila rdečih krvnih celic (anemija) in zmanjšanje števila krvnih ploščic
English: Ref.: EMEA/540887/2009 EMEA/H/C/1036
Slovenian: EMEA/540887/2009 EMEA/H/C/1036
English: This summary was last updated in 10-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2009.
English: Doc.
Slovenian: Sklic dok.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Slovenian: Če želite več informacij o podlagi za priporočila CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
English: Other information about Biopoin:
Slovenian: Druge informacije o zdravilu Biopoin:
English: Because of the risk of high blood pressure, special care should be taken to monitor and control the patient's blood pressure to avoid complications such as a hypertensive crisis.
Slovenian: Zaradi nevarnosti visokega krvnega tlaka je potrebna posebna previdnost pri spremljanju in nadzoru bolnikovega krvnega tlaka, da se preprečijo zapleti, kot je hipertenzivna kriza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Biopoin to CT Arzneimittel GmbH on 23 October 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Biopoin, veljavno po vsej Evropski uniji, odobrila družbi CT Arzneimittel GmbH dne 23. oktobra 2009.
English: The effects of Biopoin were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Biopoin so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin theta.
Slovenian: Proizvajajo ga z metodo, znano kot “tehnologija rekombinantne DNK”: izdela ga celica, ki je prejela gen (DNK), s katerim lahko tvori epoetin theta.
English: For patients with cancer, injections should be given under the skin.
Slovenian: Pri bolnikih z rakom morajo biti injekcije dane pod kožo.
English: It must not be used in patients with uncontrolled hypertension.
Slovenian: Zdravila ne smejo uporabljati osebe z nenadzorovano hipertenzijo.
English: It is available in pre-filled syringes containing between 1,000 and 30,000 international units (IU) of the active substance, epoetin theta.
Slovenian: Na voljo je v napolnjenih injekcijskih brizgah, ki vsebujejo med 1 000 in 30 000 mednarodnih enot (i.e.) zdravilne učinkovine epoetina theta.
English: What benefit has Biopoin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Biopoin izkazalo med študijami?
English: The Committee recommended that Biopoin be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Biopoin odobri dovoljenje za promet.
English: Biopoin is a solution for injection.
Slovenian: Zdravilo Biopoin je raztopina za injiciranje.
English: The most common side effects with Biopoin (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness.
Slovenian: Najpogostejši neželeni učinki zdravila Biopoin (opaženi pri 1 do 10 bolnikih izmed 100) so tromboza spoja (strdki, ki lahko nastanejo v krvnih žilah pri bolnikih na dializi, tj. tehnika čiščenja krvi), glavobol, hipertenzija (visok krvni tlak), hipertenzivna kriza (nenaden, nevarno visok krvni tlak), kožne reakcije, artralgija (bolečine v sklepih) in gripi podobna bolezen.
English: These doses may be doubled after four weeks if the improvement is not enough and may be increased further at monthly intervals by a quarter of the previous dose until the right level of haemoglobin (the protein found in red blood cells that carries oxygen around the body) is achieved.
Slovenian: Če po štirih tednih izboljšanje ni zadostno, lahko te odmerke podvojimo, v mesečnih presledkih pa jih lahko dodatno povečujemo za četrtino predhodnega odmerka, dokler se ne doseže ustrezna raven hemoglobina (beljakovine v rdečih krvničkah, ki prenaša kisik po telesu).
English: Biopoin should not be used in people who may be hypersensitive (allergic) to epoetin theta, to any other epoetins or substances derived from them, or to any of the other ingredients of Biopoin.
Slovenian: Zdravila Biopoin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin theta, na katere koli druge epoetine ali iz njih izpeljane snovi ali na katero koli drugo sestavino zdravila Biopoin.
English: The main measure of effectiveness was the average change in haemoglobin levels from 15 to 26 weeks after treatment.
Slovenian: Glavno merilo učinkovitosti je bila povprečna sprememba ravni hemoglobina od 15. do 26. tedna po zdravljenju.
English: Patients who receive Biopoin by injection under the skin may inject themselves once they have been trained appropriately.
Slovenian: Bolniki, ki prejemajo zdravilo Biopoin s podkožnim injiciranjem, si lahko zdravilo po ustreznem usposabljanju injicirajo sami.
English: There were four main studies in 842 chronic renal failure patients and three main studies in 586 nonmyeloid cancer patients receiving chemotherapy.
Slovenian: Izvedli so štiri glavne študije na 842 bolnikih s kronično ledvično odpovedjo in tri glavne študije na 586 bolnikih z nemielodnim rakom, ki so prejemali kemoterapijo.
English: This dose may be doubled after four weeks if the haemoglobin has not increased by at least 1 g/dl and can, if needed, be increased further to 60,000 IU after four additional weeks.
Slovenian: Če se po štirih tednih hemoglobin ni povišal za vsaj 1 g/dl, se lahko ta odmerek podvoji ter po potrebi po naslednjih štirih tednih poveča na 60 000 i.e.