FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, a higher percentage of patients receiving Brimica Genuair responded with a clinically meaningful improvement in SGRQ total score compared to aclidinium and formoterol (56.6% compared to 53.9% and 52.2%, respectively; p=0.603 and p=0.270, respectively).
Slovenian: Delež bolnikov, pri katerih je prišlo do klinično pomembnega izboljšanja skupne ocene SGRQ, je bil poleg tega večji pri tistih, ki so prejemali zdravilo Brimica Genuair, v primerjavi s tistimi, ki so prejemali aklidinij ali formoterol (56,6 % v primerjavi s 53,9 % in 52,2 %; p = 0,603 in p = 0,270).
English: In the pooled analysis of these two studies, Brimica Genuair showed greater improvements in SGRQ total score compared to formoterol (-1.7 units; p=0.018) or aclidinium (-0.79 units, p=0.273).
Slovenian: V zbirni analizi teh dveh študij je uporaba zdravila Brimica Genuair v primerjavi s formoterolom (-1,7 enote; p = 0,018) ali aklidinijem (-0,79 enote, p = 0,273) pokazala večje izboljšanje skupne ocene SGRQ.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija mišični krči pogosti
English: Metabolic effects of hyperglycaemia and hypokalaemia may be observed with high doses of β2-adrenergic agonists.
Slovenian: Pri visokih odmerkih agonistov β2-adrenergičnih receptorjev se lahko pojavijo presnovni učinki hiperglikemije in hipokaliemije.
English: In addition, a higher percentage of patients receiving Brimica Genuair responded with a clinically meaningful improvement in TDI focal score compared to either aclidinium or formoterol (61.9% compared to 55.7% and 57.0%, respectively; p=0.056 and p=0.100, respectively).
Slovenian: Delež bolnikov, pri katerih je prišlo do klinično pomembnega izboljšanja skupne ocene indeksa TDI, je bil večji pri tistih, ki so prejemali zdravilo Brimica Genuair, v primerjavi s tistimi, ki so prejemali aklidinij ali formoterol (61,9 % v primerjavi s 55,7 % in 57,0 %; p = 0,056 in p = 0,100).
English: The peak plasma concentrations at steady state of aclidinium and formoterol observed in patients with COPD treated with Brimica Genuair twice daily for 5 days were reached within 5 minutes post-inhalation and were 128 pg/ml and 17 pg/ml, respectively.
Slovenian: Največje plazemske koncentracije aklidinija 128 pg/ml in formoterola 17 pg/ml v stanju dinamičnega ravnovesja so bile dosežene v 5 minutah po inhalaciji pri bolnikih s KOPB, ki so pet zaporednih dni prejemali zdravilo Brimica Genuair dvakrat na dan.
English: Keep the Genuair inhaler protected inside the sealed bag until the administration period starts.
Slovenian: Inhalator Genuair hranite do uporabe zaščiten v zavarjeni vrečki.
English: Blood creatine phosphokinase increased
Slovenian: Preiskave zvišana vrednost kreatin fosfokinaze v krvi pogosti zvišan krvni tlak občasni
English: Supportive and symptomatic treatment is indicated.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika zdraviti podporno in simptomatsko.
English: Dry mouth has been observed with medicines like Brimica Genuair.
Slovenian: Pri zdravilih, kot je zdravilo Brimica Genuair, so opazili pojav suhih ust.
English: Renal impairment No dose adjustments are required in patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
English: This medicine should not be used for the treatment of asthma.
Slovenian: Tega zdravila ne smete uporabljati za zdravljenje astme, - če imate težave s srcem,
English: During the reporting period of the PSUR, study D6560C00002 was completed and showed that the proportion of patients with an adverse event of ‘peripheral oedema' was numerically lower in the aclidinium group than in the placebo group.
Slovenian: Pokazala je, da je bil delež bolnikov z neželenim učinkom "periferni edemi" v skupini z aklidinijem številsko manjši kot v skupini s placebom.
English: Angioedema Anaphylactic reaction
Slovenian: Bolezni imunskega sistema preobčutljivost redki angioedem anafilaktična reakcija neznana
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj pruritus občasni
English: Taking your medicine at regular times will also help you to remember to use it. - The recommended dose can be used for elderly patients and for patients with kidney or liver problems.
Slovenian: - Priporočen odmerek lahko uporabljajo tudi starejši bolniki in bolniki z ledvičnimi oziroma jetrnimi težavami.
English: Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms aclidinium bromide equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.
Slovenian: En dostavljen odmerek (odmerek, ki pride iz ustnika) vsebuje 396 mikrogramov aklidinijevega bromida, kar ustreza 340 mikrogramom aklidinija, in 11,8 mikrograma formoterolijevega fumarata dihidrata.
English: Each delivered dose contains 396 micrograms aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate.
Slovenian: En dostavljen odmerek vsebuje 396 mikrogramov aklidinijevega bromida (kar ustreza 340 mikrogramom aklidinija) in 11,8 mikrograma formoterolijevega fumarat dihidrata.
English: Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms of aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate.
Slovenian: En dostavljen odmerek (odmerek, ki pride iz ustnika) vsebuje 396 mikrogramov aklidinijevega bromida (kar ustreza 340 mikrogramom aklidinija) in 11,8 mikrogramov formoterolijevega fumarat dihidrata.
English: Gastrointestinal disorders
Slovenian: Antagonisti β-adrenergičnih receptorjev
English: Brimica Genuair 340 micrograms /12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Slovenian: Brimica Genuair 340 mikrogramov/12 mikrogramov prašek za inhaliranje aklidinij/formoterolijev fumarat dihidrat
English: Nasopharyngitis Urinary tract infection Sinusitis
Slovenian: Infekcijske in parazitske bolezni nazofaringitis okužba sečil sinusitis zobni absces pogosti
English: What Brimica Genuair is used for
Slovenian: Za kaj zdravilo Brimica Genuair uporabljamo
English: Grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Podlaga za spremembe pogojev dovoljenj za promet z zdravilom
English: Brimica Genuair 340 micrograms/12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Slovenian: Brimica Genuair 340/12 mikrogramov prašek za inhaliranje aklidinij/formoterolijev fumarat dihidrat
English: You should not use this medicine to treat a sudden attack of breathlessness or wheezing.
Slovenian: Zdravilo Brimica Genuair je indicirano za vzdrževalno (dolgotrajno) zdravljenje KOPB in ga ne smete uporabljati za zdravljenje nenadnega napada zadihanosti ali piskajočega dihanja.
English: No clinically relevant effects of Brimica Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Slovenian: V 6- do 12-mesečnih študijah 3. faze pri približno 4.000 bolnikih s KOPB niso opazili nobenih klinično pomembnih učinkov zdravila Brimica Genuair na parametre elektrokardiograma (vključno z intervalom QT) v primerjavi z aklidinijem, formoterolom in placebom.
English: COPD medicinal products
Slovenian: FARMACEVTSKI PODATKI
English: Headache Dizziness Tremor
Slovenian: Očesne bolezni zamegljen vid občasni
English: Renal and urinary disorders Urinary retention
Slovenian: Bolezni sečil zastajanje urina občasni
English: This medicine is for long-term use.
Slovenian: Če ste prenehali uporabljati zdravilo Brimica Genuair To zdravilo je namenjeno za dolgotrajno uporabo.
English: Brimica Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Slovenian: Brimica Genuair 340/12 µg prašek za inhaliranje aklidinij/formoterolijev fumarat dihidrat za inhaliranje
English: The MAH shall complete, within the stated timeframe, the below measure: Description
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: Brimica Genuair is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Malo verjetno je, da bi zdravilo Brimica Genuair vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: What Brimica Genuair is
Slovenian: Kaj je zdravilo Brimica Genuair
English: Dysphonia Throat irritation
Slovenian: Psihiatrične motnje nespečnost tesnoba pogosti vznemirjenost občasni
English: MA (EU) Number Name Strength Pharmaceutical Form Route of Administration
Slovenian: Številka (EU) dovoljenja za promet
English: Ifirmasta 75 mg Film-coated tablet
Slovenian: Pot uporabe Stična ovojnina
English: Date of first authorisation: 8 December 2017
Slovenian: Datum prve odobritve: 8. december 2017
English: blindness not known:
Slovenian: slepota neznana:
English: 4042 Debrecen
Slovenian: 4042 Debrecen Madžarska
English: If you have forgotten to take your capsules in the morning, take them as soon as possible on the same day.
Slovenian: Če ste zjutraj kapsule pozabili vzeti, jih vzemite isti dan takoj, ko je to možno.
English: Prilaz baruna Filipovica 25 10 000 Zagreb Croatia
Slovenian: Prilaz baruna Filipovica 25 10 000 Zagreb Hrvaška
English: Tacforius with food and drink
Slovenian: Zdravilo Tacforius skupaj s hrano in pijačo
English: C/C, n. 4, Poligono Industrial Malpica ES-50016 Zaragoza Spain
Slovenian: C/C, n. 4, Poligono Industrial Malpica ES-50016 Zaragoza Španija
English: This may cause allergic reactions.
Slovenian: Povzroča lahko alergijske reakcije.
English: Elderly There is no evidence currently available to indicate that dosing should be adjusted in the elderly.
Slovenian: Starejši Trenutno ni dokazov, da bi bila pri starejših potrebna prilagoditev odmerjanja.
English: Tacforius reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Slovenian: Zdravilo Tacforius omeji vaše telesne obrambne mehanizme (imunski sistem), ki ne bodo tako dobri pri premagovanju okužb.
English: If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Slovenian: Če videz tega zdravila ni enak kot običajno ali so se spremenila navodila za jemanje, se čimprej pogovorite z zdravnikom ali farmacevtom, da zagotovite, da imate pravo zdravilo.
English: Take Tacforius on an empty stomach or 2 to 3 hours after a meal.
Slovenian: Zdravilo Tacforius vzemite na prazen želodec ali 2 do 3 ure po jedi.
English: Teva Pharmaceutical Works Private Limited Company Pallagi Ut 13
Slovenian: Teva Pharmaceutical Works Private Limited Company
English: EU/1/17/1244/001 30 capsules EU/1/17/1244/002 30x1 capsules EU/1/17/1244/003 50 capsules EU/1/17/1244/004 50x1 capsules EU/1/17/1244/005 100 capsules EU/1/17/1244/006 100x1 capsules EU/1/17/1244/007 30 capsules EU/1/17/1244/008 30x1 capsules EU/1/17/1244/009 50 capsules EU/1/17/1244/010 50x1 capsules EU/1/17/1244/011 60 capsules EU/1/17/1244/012 60x1 capsules EU/1/17/1244/013 100 capsules EU/1/17/1244/014 100x1 capsules EU/1/17/1244/015 30 capsules EU/1/17/1244/016 30x1 capsules EU/1/17/1244/017 50 capsules EU/1/17/1244/018 50x1 capsules EU/1/17/1244/019 100 capsules EU/1/17/1244/020 100x1 capsules EU/1/17/1244/021 30 capsules EU/1/17/1244/022 30x1 capsules EU/1/17/1244/023 50 capsules EU/1/17/1244/024 50x1 capsules
Slovenian: EU/1/17/1244/001 30 kapsul EU/1/17/1244/002 30x1 kapsula EU/1/17/1244/003 50 kapsul EU/1/17/1244/004 50x1 kapsula EU/1/17/1244/005 100 kapsul EU/1/17/1244/006 100x1 kapsula EU/1/17/1244/007 30 kapsul EU/1/17/1244/008 30x1 kapsula EU/1/17/1244/009 50 kapsul EU/1/17/1244/010 50x1 kapsula EU/1/17/1244/011 60 kapsul EU/1/17/1244/012 60x1 kapsula EU/1/17/1244/013 100 kapsul EU/1/17/1244/014 100x1 kapsula EU/1/17/1244/015 30 kapsul EU/1/17/1244/016 30x1 kapsula EU/1/17/1244/017 50 kapsul EU/1/17/1244/018 50x1 kapsula EU/1/17/1244/019 100 kapsul EU/1/17/1244/020 100x1 kapsula EU/1/17/1244/021 30 kapsul EU/1/17/1244/022 30x1 kapsula EU/1/17/1244/023 50 kapsul
English: Tacforius is used in adults.
Slovenian: Zdravilo Tacforius se uporablja pri odraslih.
English: Administration should commence approximately 12 - 18 hours after the completion of surgery.
Slovenian: Začeti se mora približno 12-18 ur po koncu operacije.
English: Tacforius doses are usually reduced in the post-transplant period.
Slovenian: Odmerki zdravila Tacforius se med obdobjem po presaditvi ponavadi zmanjšajo.
English: Tell your doctor if any of the following apply to you: - if you are taking any medicines mentioned below under “Other medicines and Tacforius”.
Slovenian: Povejte svojemu zdravniku, če za vas velja sledeče: - jemljete katero koli zdravilo, ki je omenjeno v nadaljevanju v poglavju “Druga zdravila in zdravilo Tacforius”,
English: 2031GA Haarlem Netherlands
Slovenian: 2031GA Haarlem
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Certain combinations of tacrolimus with substances known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Slovenian: Določene kombinacije takrolimusa s snovmi, za katere je znano, da imajo nefrotoksične ali nevrotoksične učinke, lahko povečajo tveganje za te učinke (glejte poglavje 4.5).
English: If you need to have any vaccinations, please tell your doctor before.
Slovenian: Če morate opraviti cepljenje s katerim koli cepivom, to prej povejte svojemu zdravniku.
English: You will need to take Tacforius every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Slovenian: Zdravilo Tacforius boste morali jemati vsak dan, dokler potrebujete imunosupresijo za preprečitev zavrnitve presajenega organa.
English: The safety and efficacy of Tacforius in children under 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Tacforius pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: No studies on the effects of tacrolimus on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu takrolimusa (Tacforius) na sposobnost vožnje in upravljanja strojev niso izvedli.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake ''EXP''.
English: Ísland ratiopharm Oy Finnland
Slovenian: Ísland ratiopharm Oy
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Tacforius.
Slovenian: Ker ni mogoče izključiti škodljivih učinkov na novorojenčka, ženske med uporabo zdravila Tacforius ne smejo dojiti.
English: Teva Italia S.r.l.
Slovenian: Italia Teva Italia S.r.l.
English: From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Tacforius.
Slovenian: Zdravnik vam bo od časa do časa moral narediti preiskave krvi, urina, srca in vida, da bo določil pravi odmerek zdravila Tacforius.
English: What Tacforius is and what it is used for
Slovenian: Kaj je zdravilo Tacforius in za kaj ga uporabljamo
English: Not known (frequency cannot be estimated from the available data) - Abnormality of the optic nerve (optic neuropathy)
Slovenian: Neznana (ni mogoče oceniti iz razpoložljivih podatkov) - prizadetost vidnega živca (nevropatija vidnega živca)
English: There is a risk for premature delivery (<37 week) (incidence of 66 of 123 births, i.e. 53.7%; however, data showed that the majority of the newborns had normal birth weight for their gestational age) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i.e. 7.2%) which, however normalises spontaneously.
Slovenian: Obstaja tveganje za prezgoden porod (< 37 tednov) (pri 66 od 123 rojstev, tj. pojavnost 53,7 %; vendar podatki kažejo, da je imela večina novorojenčkov normalno telesno maso za njihovo gestacijsko starost) in za hiperkaliemijo pri novorojenčku (pri 8 od 111 novorojenčkov; pojavnost 7,2 %), ki pa se normalizira sama od sebe.
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Tacforius.
Slovenian: Pri tej skupini bolnikov je pred začetkom zdravljenja z zdravilom Tacforius treba izvesti serološko testiranje na EBV-VCA.
English: Stopping your treatment with Tacforius may increase the risk of rejection of your transplanted organ.
Slovenian: Prekinitev zdravljenja z zdravilom Tacforius lahko poveča tveganje za zavrnitev presajenega organa.
English: Accordingly, highrisk patients receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9 - 12 months).
Slovenian: Glede na to je treba zelo ogrožene bolnike, ki se zdravijo z intenzivno imunosupresijo, nadzorovati s preiskavami, kot sta ehokardiografija ali EKG, in sicer pred presaditvijo in po njej (npr. uvodoma po 3 mesecih in potem pri 9-12 mesecih).
English: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Slovenian: 4.3 Kontraindikacije Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Teva Pharmaceuticals Ireland L-Irlanda
Slovenian: Ireland Teva Pharmaceuticals Ireland
English: The use of Tacforius is not recommended in children and adolescents under 18 years.
Slovenian: Otroci in mladostniki Uporaba zdravila Tacforius ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
English: Tell your doctor immediately if during treatment you suffer from: - problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Slovenian: Nemudoma obvestite zdravnika, če se vam med zdravljenjem pojavijo: - težave z vidom, npr. zamegljen vid, spremembe barvnega vida, težave pri videnju podrobnosti ali zožitev vidnega polja.
English: Limited data are available but no recommendation on a posology can be made.
Slovenian: Na voljo je malo podatkov, zato priporočil o odmerjanju ni mogoče dati.
English: Tacforius should be administered in the morning.
Slovenian: Tacforius zjutraj.
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Tacforius may need to be reduced.
Slovenian: Če se pojavijo znaki toksičnosti, na primer resni neželeni učinki (glejte poglavje 4.8), bo odmerek zdravila Tacforius morda treba zmanjšati.
English: In case of in utero exposure, monitoring of the newborn for the potential adverse reactions of tacrolimus is recommended (in particular effects on the kidneys).
Slovenian: V primeru izpostavljenosti in utero je novorojenčka priporočljivo nadzirati glede možnih neželenih reakcij na takrolimus (zlasti učinki na ledvice).
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the halflife of pentobarbital and antipyrine.
Slovenian: Podatki, zbrani na živalih, kažejo, da bi takrolimus lahko zmanjšal očistek in podaljšal razpolovni čas pentobarbitala in antipirina.
English: Contents of the pack and other information What Tacforius contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Tacforius
English: Bile flow does not influence the absorption of tacrolimus and therefore treatment with Tacforius may commence orally.
Slovenian: Tok žolča ne vpliva na absorpcijo takrolimusa, zato se zdravljenje z zdravilom Tacforius lahko začne peroralno.
English: Tacrolimus blood trough levels should be determined approximately 24 hours post-dosing of Tacforius, just prior to the next dose.
Slovenian: Najnižjo koncentracijo takrolimusa je treba določiti približno 24 ur po uporabi zdravila Tacforius, tik pred naslednjim odmerkom.
English: 98.8%) to plasma proteins, mainly to serum albumin and α - 1-acid glycoprotein.
Slovenian: V plazmi je takrolimus v veliki meri (> 98,8 %) vezan na plazemske beljakovine, predvsem na serumski albumin in α-1-kisli glikoprotein.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze naj tega zdravila ne jemljejo.
English: If patients taking tacrolimus present with symptoms indicating PRES such as headache, altered mental status, seizures, and visual disturbances, a radiological procedure (e.g. MRI) should be performed.
Slovenian: Če se pri bolnikih, ki jemljejo takrolimus, pojavijo znaki, ki kažejo na PRES, kot so glavobol, spremenjeno duševno stanje, epileptični napadi in motnje vida, je treba izvesti radiološko slikanje (npr. MRI).
English: In prospective studies oral tacrolimus immediate release capsules was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Slovenian: V prospektivnih študijah so takrolimus v peroralni obliki kapsul s takojšnjim sproščanjem raziskovali kot primarni imunosupresiv pri približno 175 bolnikih po presaditvi pljuč, 475 bolnikih po presaditvi pankreasa in 630 bolnikih po presaditvi črevesa.
English: Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells) and haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) have been reported.
Slovenian: Poročali so o primerih čiste aplazije rdečih krvnih celic (hudo zmanjšanje števila rdečih krvnih celic), agranulocitozi (hudo zmanjšanje števila belih krvnih celic) in hemolitični anemiji (zmanjšano število rdečih krvnih celic zaradi nenormalnega razpada).
English: Tacforius therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Slovenian: Zdravljenje z zdravilom Tacforius je treba začeti upoštevaje koncentracijo ciklosporina v krvi in bolnikovo klinično stanje.
English: You may also be given Tacforius for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.
Slovenian: Zdravilo Tacforius lahko dobite tudi zaradi zavračanja presajenih jeter, ledvic, srca ali drugega organa, če zdravila, ki ste jih jemali pred tem, niso obvladala imunskega odziva po presaditvi.
English: Acute rejection episodes per 100 patient-days were numerically fewer in the tacrolimus (0.85 episodes) than in the ciclosporin group (1.09 episodes).
Slovenian: Številčno je bilo akutnih zavrnitvenih epizod na 100 bolnikov-dni v skupini s takrolimusom manj (0,85 epizode) kot v skupini s ciklosporinom (1,09 epizode).