FrancophonIA/ELRC3.0 huggingface dataset:
English: Because renal elimination is the major elimination pathway, dose reduction in patients with renal impairment and dose supplementation following haemodialysis is necessary (see section 4.2 Table 1).
Slovenian: Ker je izločanje skozi ledvice glavna eliminacijska pot, je treba pri bolnikih z okvaro ledvic odmerek zmanjšati, po hemodializi pa ustrezen odmerek dodati (glejte poglavje 4.2, preglednico 1).
English: Reduced lower gastrointestinal tract function There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Slovenian: Zmanjšano delovanje spodnjega gastrointestinalnega trakta V obdobju trženja so ob sočasni uporabi pregabalina z zdravili, ki povzročajo zaprtost, kot npr. opioidni analgetiki, poročali o učinkih, povezanih z zmanjšanjem delovanja spodnjega gastrointestinalnega trakta (npr. črevesna zapora, paralitični ileus, zaprtje).
English: • Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
Slovenian: • trzanje mišic, otekanje sklepov, mišična togost, bolečina, vključno z bolečino v mišicah,
English: • Pregabalin Mylan has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Slovenian: • Zdravljenje z zdravilom Pregabalin Mylan lahko spremljata omotica in zaspanost, ki lahko pri starejših bolnikih zvečata pogostnost nezgodnih poškodb (padcev).
English: In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNC adverse reactions and especially somnolence was increased (see section 4.4).
Slovenian: Pri zdravljenju centralne nevropatske bolečine kot posledice poškodbe hrbtenjače je bila povečana incidenca neželenih učinkov na splošno, neželenih učinkov, povezanih z osrednjim živčnim sistemom, in še posebno somnolence (glejte poglavje 4.4).
English: What Pregabalin Mylan looks like and contents of the pack Hard capsule.
Slovenian: Izgled zdravila Pregabalin Mylan in vsebina pakiranja trda kapsula
English: If you forget to take Pregabalin Mylan
Slovenian: Če ste pozabili vzeti zdravilo Pregabalin Mylan
English: Pregabalin Mylan may be taken with oral contraceptives.
Slovenian: Zdravilo Pregabalin Mylan lahko jemljete s peroralnimi kontraceptivi.
English: Very rare: may affecr up to 1 in 10,000 people
Slovenian: Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov
English: Pregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Slovenian: Zdravilo Pregabalin Mylan je indicirano za zdravljenje generalizirane anksiozne motnje (GADGeneralised Anxiety Disorder) pri odraslih.
English: Stevens Johnson syndrome, cold sweat
Slovenian: Stevens-Johnsonov sindrom, hladen znoj Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti
English: Do not stop taking Pregabalin Mylan unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Pregabalin Mylan Ne prenehajte jemati zdravila Pregabalin Mylan, razen če vam to naroči zdravnik.
English: Tel: +372 6363 052
Slovenian: Tel:+372 6363 052 (Ühendkuningriik)
English: In the controlled clinical trial in central neuropathic pain 22% of the pregabalin treated patients and 7% of the patients on placebo had a 50% improvement in pain score.
Slovenian: V kontroliranem kliničnem preskušanju centralne nevropatske bolečine je 22 % bolnikov, ki so prejemali pregabalin, in 7 % bolnikov, ki so prejemali placebo, izkusilo 50 %-no izboljšanje v točkovanju bolečine.
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either twice a day dosing (BID) or three times a day (TID) dosing.
Slovenian: Pregabalin so preučevali v 3 kontroliranih kliničnih preskušanjih v trajanju 12 tednov z odmerjanjem 2-krat in 3-krat na dan.
English: For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Slovenian: Od bolnikov, ki so izkusili somnolenco, jih je poročalo o izboljšanju 48 %, ki so prejemali pregabalin, in 16 %, ki so prejemali placebo.
English: In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
Slovenian: V kontroliranem kliničnem preskušanju periferne nevropatske bolečine je 35 % bolnikov, ki so prejemali pregabalin, in 18 % bolnikov, ki so prejemali placebo, izkusilo 50 %-no izboljšanje v točkovanju bolečine.
English: Pregabalin Mylan 25 mg hard capsules Pregabalin Mylan 50 mg hard capsules Pregabalin Mylan 75 mg hard capsules Pregabalin Mylan 100 mg hard capsules Pregabalin Mylan 150 mg hard capsules Pregabalin Mylan 200 mg hard capsules Pregabalin Mylan 225 mg hard capsules Pregabalin Mylan 300 mg hard capsules
Slovenian: Pregabalin Mylan 25 mg trde kapsule Pregabalin Mylan 50 mg trde kapsule Pregabalin Mylan 75 mg trde kapsule Pregabalin Mylan 100 mg trde kapsule Pregabalin Mylan 150 mg trde kapsule Pregabalin Mylan 200 mg trde kapsule Pregabalin Mylan 225 mg trde kapsule Pregabalin Mylan 300 mg trde kapsule pregabalin
English: Pregabalin Mylan is for oral use only.
Slovenian: Zdravilo Pregabalin Mylan je samo za peroralno uporabo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/997/022
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/997/022
English: For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% of patients on placebo.
Slovenian: Od bolnikov, ki niso izkusili somnolence, jih je o izboljšanju poročalo 33 %, ki so prejemali pregabalin, in 18 %, ki so prejemali placebo.
English: Blood creatine phosphokinase increased, blood glucose increased, platelet count decreased, blood creatinine increased, blood potassium decreased, weight decreased
Slovenian: Redki zvečanje telesne mase zvišanje keratin fosfokinaze v krvi, zvišanje glukoze v krvi, zmanjšanje števila trombocitov, zvišanje kreatinina v krvi, zmanjšanje telesne mase zmanjšanje števila levkocitov
English: Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Slovenian: (< 2 % odmerka se pojavi v urinu v obliki presnovkov), ne zavira presnove zdravil in vitro in ni vezan na beljakovine v plazmi.
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujtez zdravnikom ali farmacevtom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/997/034
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/997/034
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/997/050
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/997/050
English: After stopping long and short-term Pregabalin Mylan treatment, you need to know that you may experience certain side effects.
Slovenian: Po koncu dolgoročnega ali kratkoročnega zdravljenja z zdravilom Pregabalin Mylan se lahko pri vas pojavijo določeni neželeni učinki.
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring
Slovenian: • preobčutljivost, oteklost obraza, srbenje, koprivnica, izcedek iz nosu, krvavitve iz nosu, kašelj,
English: PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules.
Slovenian: PVC/PVDC/aluminijev pretisni omot s po 14, 21, 56, 84 in 100 trdimi kapsulami.
English: How to take Pregabalin Mylan
Slovenian: Kako jemati zdravilo Pregabalin Mylan
English: Pregabalin Mylan may produce dizziness, sleepiness and decreased concentration.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pregabalin Mylan lahko povzroči omotico, zaspanost in poslabša sposobnost koncentracije.
English: sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness,
Slovenian: občutljiva koža, izguba okusa, pekoč občutek, tresenje pri usmerjenih gibih, poslabšano zavedanje, izguba zavesti, omedlevica, povečana občutljivost za hrup, slabo počutje
English: PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules.
Slovenian: PVC/PVDC/aluminijev pretisni omot s po 14, 56 in 100 trdimi kapsulami.
English: PVC/PVDC-Al blister pack containing 21, 84 and 100 hard capsules.
Slovenian: PVC/PVDC/aluminijev pretisni omot s po 21, 84 in 100 trdimi kapsulami.
English: INFORMATION IN BRAILLE Pregabalin Mylan 225 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 225 mg
English: • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
Slovenian: • spremembe v dojemanju sebe, nemir, depresija, tesnoba, nihanje razpoloženja, težave pri iskanju besed, halucinacije, nenormalne sanje, napad panike, otopelost, agresija, vzneseno razpoloženje,
English: Pregabalin Mylan 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin.
Slovenian: Pregabalin Mylan 75 mg trde kapsule Ena trda kapsula vsebuje 75 mg pregabalina.
English: Pregabalin Mylan 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Slovenian: Pregabalin Mylan 225 mg trde kapsule Ena trda kapsula vsebuje 225 mg pregabalina.
English: Pregabalin Mylan 225 mg hard capsule
Slovenian: Pregabalin Mylan 225 mg trde kapsule
English: Pregabalin Mylan 75 mg hard capsules EU/1/15/997/016
Slovenian: Pregabalin Mylan 75 mg trde kapsule EU/1/15/997/016
English: Erectile dysfunction Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain Amenorrhoea, breast discharge, breast enlargement, gynaecomastia
Slovenian: Redki motnje erekcije spolna disfunkcija, zapoznela ejakulacija, dismenoreja, bolečine v dojkah amenoreja, izcedek iz dojk, povečanje dojk, ginekomastija Splošne težave in spremembe na mestu aplikacije Pogosti
English: INFORMATION IN BRAILLE Pregabalin Mylan 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 75 mg
English: Pregabalin Mylan 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin.
Slovenian: Pregabalin Mylan 200 mg trde kapsule Ena trda kapsula vsebuje 200 mg pregabalina.
English: Pregabalin Mylan 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Slovenian: Pregabalin Mylan 300 mg trde kapsule Ena trda kapsula vsebuje 300 mg pregabalina.
English: Pregabalin Mylan 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Slovenian: Pregabalin Mylan 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg pregabalina.
English: Pregabalin Mylan 100 mg hard capsules EU/1/15/997/023
Slovenian: Pregabalin Mylan 100 mg trde kapsule EU/1/15/997/023
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov Občasni
English: Pregabalin Mylan 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin.
Slovenian: Pregabalin Mylan 150 mg trde kapsule Ena trda kapsula vsebuje 150 mg pregabalina.
English: INFORMATION IN BRAILLE Pregabalin Mylan 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 150 mg
English: • There have been reports of kidney failure in some patients when taking Pregabalin Mylan.
Slovenian: • Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Mylan, so opisani primeri odpovedi ledvic.
English: What Pregabalin Mylan contains
Slovenian: Kaj vsebuje zdravilo Pregabalin Mylan
English: INFORMATION IN BRAILLE Pregabalin Mylan 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 200 mg
English: Pregabalin Mylan 150 mg hard capsule
Slovenian: Pregabalin Mylan 150 mg trde kapsule
English: Pregabalin Mylan 225 mg hard capsules EU/1/15/997/040
Slovenian: Pregabalin Mylan 225 mg trde kapsule EU/1/15/997/040
English: Pregabalin Mylan 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin.
Slovenian: Pregabalin Mylan 25 mg trde kapsule Ena trda kapsula vsebuje 25 mg pregabalina.
English: • There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Mylan when they have other conditions.
Slovenian: • Pri nekaterih bolnikih, ki jemljejo zdravilo Pregabalin Mylan in imajo tudi druge težave z zdravjem, so poročali o zmanjšanju možganske funkcije (encefalopatiji).
English: Pregabalin Mylan 200 mg hard capsules EU/1/15/997/035
Slovenian: Pregabalin Mylan 200 mg trde kapsule EU/1/15/997/035
English: Pregabalin Mylan 300 mg hard capsules EU/1/15/997/045
Slovenian: Pregabalin Mylan 300 mg trde kapsule EU/1/15/997/045
English: Pregabalin Mylan 75 mg hard capsule
Slovenian: Pregabalin Mylan 75 mg trde kapsule
English: Pregabalin Mylan 100 mg hard capsule
Slovenian: Pregabalin Mylan 100 mg trde kapsule
English: INFORMATION IN BRAILLE Pregabalin Mylan 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 100 mg
English: Pregabalin Mylan 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin.
Slovenian: Pregabalin Mylan 50 mg trde kapsule Ena trda kapsula vsebuje 50 mg pregabalina.
English: INFORMATION IN BRAILLE Pregabalin Mylan 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 300 mg
English: Pregabalin Mylan 200 mg hard capsule
Slovenian: Pregabalin Mylan 200 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 75 mg hard capsules pregabalin
Slovenian: IME ZDRAVILA Pregabalin Mylan 75 mg trde kapsule pregabalin
English: INFORMATION IN BRAILLE Pregabalin Mylan 25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 25 mg
English: INFORMATION IN BRAILLE Pregabalin Mylan 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Pregabalin Mylan 50 mg
English: Pregabalin Mylan 300 mg hard capsule
Slovenian: Pregabalin Mylan 300 mg trde kapsule
English: Pregabalin Mylan 150 mg hard capsules EU/1/15/997/028
Slovenian: Pregabalin Mylan 150 mg trde kapsule EU/1/15/997/028
English: Pregabalin Mylan 50 mg hard capsules EU/1/15/997/009
Slovenian: Pregabalin Mylan 50 mg trde kapsule EU/1/15/997/009
English: Pregabalin Mylan 25 mg hard capsules EU/1/15/997/001
Slovenian: Pregabalin Mylan 25 mg trde kapsule EU/1/15/997/001
English: Pregabalin Mylan 50 mg hard capsule
Slovenian: Pregabalin Mylan 50 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 50 mg hard capsules pregabalin
Slovenian: IME ZDRAVILA Pregabalin Mylan 50 mg trde kapsule pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 225 mg hard capsules pregabalin
Slovenian: Pregabalin Mylan 225 mg trde kapsule pregabalin
English: Pregabalin Mylan 25 mg hard capsule
Slovenian: Pregabalin Mylan 25 mg trde kapsule
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 25 mg hard capsules pregabalin
Slovenian: IME ZDRAVILA Pregabalin Mylan 25 mg trde kapsule pregabalin
English: No. 2, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Slovenian: Trda želatinasta kapsula, velikosti št. 2, z neprozornim telesom kapsule svetlo breskove barve in belim neprozornim pokrovčkom kapsule.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 100 mg hard capsules pregabalin
Slovenian: Pregabalin Mylan 100 mg trde kapsule pregabalin
English: Date of last renewal: DDMMYY
Slovenian: Datum zadnjega podaljšanja:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: http://www.ema.europa.eu/.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 150 mg hard capsules pregabalin
Slovenian: Pregabalin Mylan 150 mg trde kapsule pregabalin
English: Pregabalin Mylan 75 mg hard capsules No. 4, light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Slovenian: Trda želatinasta kapsula, velikosti št. 4, z belim neprozornim telesom kapsule in neprozornim pokrovčkom kapsule svetlo breskove barve.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan 200 mg hard capsules pregabalin
Slovenian: Pregabalin Mylan 200 mg trde kapsule pregabalin
English: No. 3, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Slovenian: Trda želatinasta kapsula, velikosti št. 3, z belim neprozornim telesom kapsule in neprozornim pokrovčkom kapsule temno breskove barve.
English: No. 0, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Slovenian: Trda želatinasta kapsula, velikosti št. 0, z neprozornim belim telesom kapsule in neprozornim pokrovčkom capsule svetlo breskove barve.
English: No. 1, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Slovenian: Trda želatinasta kapsula, velikosti št. 1, z neprozornim telesom in pokrovčkom kapsule temno breskove barve.
English: What benefit has Vfend shown during the studies?
Slovenian: Kakšne koristi je zdravilo Vfend izkazalo med študijami?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vfend on 19 March 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vfend, veljavno po vsej Evropski uniji, izdala 19. marca 2002.
English: What measures are being taken to ensure the safe and effective use of Vfend?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vfend?
English: The full EPAR for Vfend can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vfend je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness in all these studies was the number of patients who had a complete or partial response to treatment.
Slovenian: Glavno merilo učinkovitosti pri vseh študijah je bilo število bolnikov, ki so se v celoti ali delno odzvali na zdravljenje.
English: In most of these (15 out of 24), the response was complete.
Slovenian: V večini primerov (15 bolnikih od 24) je bil odziv popoln.
English: ‘Refractory' means that the infections were not responding to treatment.
Slovenian: „Neodzivne“ pomeni, da se okužbe niso odzivale na zdravljenje.
English: Vfend must not be used in patients who are taking any of the following medicines:
Slovenian: Zdravila Vfend ne smejo uporabljati bolniki, ki jemljejo katero koli od naslednjih zdravil:
English: Treatment beyond 180 days requires careful assessment to ensure that the benefits continue to outweigh the risk for the patient.
Slovenian: Pri zdravljenju, daljšemu od 180 dni, je treba opraviti temeljito oceno in s tem zagotoviti, da koristi za bolnika še naprej odtehtajo tveganja.
English: Vfend has also been studied in 285 children.
Slovenian: Zdravilo Vfend so proučevali tudi pri 285 otrocih.
English: Other information about Vfend
Slovenian: Druge informacije o zdravilu Vfend
English: The aim of the loading dose is to reach stable blood levels.
Slovenian: Namen udarnega odmerka je, da dosežemo stabilne ravni zdravila v krvi.
English: It is available as tablets (50 mg or 200 mg), as an oral suspension (40 mg/ml) and as a powder to be made up into a solution for infusion (drip into a vein).
Slovenian: Na voljo je v obliki tablet (50 mg ali 200 mg), kot peroralna suspenzija (40 mg/ml) in kot prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: Vfend is given twice a day at least one hour before or one hour after a meal.
Slovenian: Zdravilo Vfend se jemlje dvakrat na dan vsaj eno uro pred obrokom ali eno uro po njem.
English: Caution is also needed when Vfend is taken at the same time as other medicines.
Slovenian: Prav tako je potrebna previdnost pri sočasnem jemanju zdravila Vfend z drugimi zdravili.
English: Vfend is used for the treatment of adults and children over the age of two years who have the following fungal infections:
Slovenian: Zdravilo Vfend se uporablja za zdravljenje odraslih in otrok, starejših od dveh let, ki imajo naslednje glivične okužbe:
English: • ritonavir (used to treat HIV infection) at doses of 400 mg or more twice a day;
Slovenian: • ritonavir (zdravilo za zdravljenje okužbe z virusom HIV), če odmerki znašajo 400 mg ali več dvakrat na dan;
English: The most common side effects with Vfend (seen in more than 1 patient in 10) are peripheral oedema (swelling of the arms and legs), headache, visual disturbances (including blurred vision, changes in colour perception and excessive sensitivity to light), respiratory distress (difficulty breathing), abdominal pain (stomach ache), nausea (feeling sick), vomiting, diarrhoea, rash and pyrexia (fever) and abnormal liver function test results.
Slovenian: Najpogostejši neželeni učinki zdravila Vfend (opaženi pri več kot 1 bolniku od 10) so periferni edemi (otekanje rok in nog), glavobol, motnje vida (vključno z zamegljenim vidom, spremembami v zaznavanju barv in pretirano občutljivostjo za svetlobo), dihalna stiska (oteženo dihanje), bolečine v trebuhu, navzeja (slabost), bruhanje, driska, izpuščaji in pireksija (povišana telesna temperatura) ter neobičajni rezultati jetrnih testov.
English: Treatment duration should be as short as possible.
Slovenian: Zdravljenje mora biti čim krajše.
English: A risk management plan has been developed to ensure that Vfend is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vfend je bil pripravljen načrt obvladovanja tveganj.
English: The tablets and suspension are to be taken at least one hour before or after a meal.
Slovenian: Tablete in suspenzijo je treba vzeti vsaj eno uro pred obrokom ali najmanj eno uro po njem.
English: The CHMP decided that Vfend's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Vfend večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Preventive treatment should last for as short a time as possible.
Slovenian: Preventivno zdravljenje mora biti čim krajše.
English: For more information about treatment with Vfend, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vfend preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Most patients receiving Vfend treatment for these rare infections did not tolerate or did not respond to prior treatment with other antifungal medicines.
Slovenian: Večina bolnikov, ki so prejeli zdravilo Vfend za te redke okužbe, ni prenesla predhodnega zdravljenja z drugimi zdravili proti glivicam ali pa se ni odzvala nanj.
English: It works by disrupting the formation of ergosterol, which is an important component of fungal cell membranes.
Slovenian: Deluje tako, da ovira tvorbo ergosterola, ki je pomembna sestavina celičnih membran glivic.
English: EPAR summary for the public voriconazole
Slovenian: Povzetek EPAR za javnost vorikonazol
English: It may be continued for a further 80 days but only if the patient's immune system is still suppressed or if they develop graft-versus-host disease (when the transplanted cells start attacking the body's own cells).
Slovenian: Lahko se nadaljuje še nadaljnjih 80 dni, a le, če je bolnikov imunski sistem še vedno zavrt oziroma če se pri njemu razvije bolezen presadka proti gostitelju (kadar začnejo presajene celice napadati lastne celice telesa).
English: Why has Vfend been approved?
Slovenian: Zakaj je bilo zdravilo Vfend odobreno?
English: This is a summary of the European public assessment report (EPAR) for Vfend.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vfend.