FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets should be swallowed whole with fluid (preferably water) immediately following removal from the blister.
Slovenian: Bolnik mora tablete takoj po odstranitvi pretisnega omota pogoltniti cele skupaj s tekočino (najbolje z vodo).
English: Human data show that tacrolimus crosses the placenta.
Slovenian: Podatki pri ljudeh kažejo, da takrolimus prehaja skozi placento.
English: Envarsus blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Envarsus, which may require interruption, an increase or a decrease in Envarsus dose.
Slovenian: Druga zdravila, ki jih jemljete, lahko vplivajo na koncentracijo zdravila Envarsus v krvi, pa tudi jemanje zdravila Envarsus lahko vpliva na koncentracijo drugih zdravil v krvi, zato bo morda treba odmerek zdravila Envarsus povečati ali zmanjšati.
English: Results from clinical studies performed with once-daily tacrolimus
Slovenian: Rezultati kliničnih študij, opravljenih s takrolimusom enkrat na dan Presaditev ledvic
English: Concomitant use of substances known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels.
Slovenian: Sočasna uporaba zdravil ali zeliščnih pripravkov, ki zavirajo ali inducirajo CYP3A4, lahko vpliva na presnovo takrolimusa in zviša ali zniža njegovo koncentracijo v krvi.
English: Treatment emergent fatal adverse events occurred in 1.2% of Envarsus patients and 0.6% of Prograf patients.
Slovenian: Smrtni dogodki, povezani z zdravljenjem, so se pojavili pri 1,2 % bolnikov, zdravljenih z zdravilom Envarsus, in pri 0,6 % bolnikov, zdravljenih z zdravilom Prograf.
English: cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Slovenian: Bolnike, ki prejemajo imunosupresive, bolj ogroža pojav malignomov.
English: Do not take a double dose to make up for a forgotten tablet.
Slovenian: Če ste pozabili vzeti zdravilo Envarsus Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: 3 blisters are packed together in an aluminium foil wrapper containing a desiccant.
Slovenian: 3 pretisni omoti so pakirani skupaj v ovitku iz aluminijaste folije s sušilnim sredstvom.
English: Patients are also at an increased risk of infections with viral hepatitis (e.g. hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Slovenian: (na primer reaktivacija okužbe s hepatitisom B ali C ali prva okužba z njima, kot tudi s hepatitisom E, ki lahko postane kronična).
English: Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient aided by whole blood tacrolimus trough level monitoring.
Slovenian: Odmerjanje mora temeljiti predvsem na klinični oceni zavrnitve in prenašanja pri vsakem bolniku posebej s pomočjo spremljanja najnižje koncentracije takrolimusa v krvi.
English: Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel.
Slovenian: Zdravilo Envarsus je peroralna farmacevtska oblika takrolimusa, ki se ga jemlje enkrat na dan. Zdravljenje s takrolimusom mora natančno nadzorovati ustrezno usposobljeno in opremljeno osebje.
English: In plasma, tacrolimus is highly bound (>98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Slovenian: vezan na plazemske beljakovine, predvsem na serumski albumin in α-1-kisli glikoprotein.
English: Therefore, Envarsus should generally be taken on an empty stomach to achieve maximal absorption.
Slovenian: Zato je treba za dosego največje absorpcije zdravilo Envarsus praviloma jemati na prazen želodec.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Elderly patients (> 65 years) There is no evidence currently available to indicate that dose should be adjusted in elderly patients.
Slovenian: Trenutno ni dokazov, da bi bila pri starejših bolnikih potrebna prilagoditev odmerjanja.
English: Some cases have reported resolution on switching to alternative immunosuppression.
Slovenian: V nekaterih primerih so poročali o prenehanju teh motenj prehodu na drugo imunosupresivno zdravljenje.
English: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
Slovenian: Pri bolnikih, ki so dobivali takrolimus, so opisane alergijske in anafilaktoidne reakcije (glejte poglavje 4.4).
English: Treatment-emergent fatal adverse events occurred in 1.8% of Envarsus patients and 2.5% of Prograf patients.
Slovenian: Smrtni dogodki, povezani z zdravljenjem, so se pojavili pri 1,8 % bolnikov, zdravljenih z zdravilom Envarsus, in pri 2,5 % bolnikov, zdravljenih z zdravilom Prograf.
English: In clinical studies patients converted from twice daily Prograf were converted to Envarsus at 1:0.85 (mg:mg).
Slovenian: V kliničnih študijah so pri prehodu bolnikov z zdravila Prograf dvakrat na dan na zdravilo Envarsus uporabili razmerje 1:0,85 (mg:mg).
English: Envarsus therapy should commence at a dose of 0.17 mg/kg/day administered once daily in the morning.
Slovenian: Profilaksa zavrnitve presajene ledvice Zdravljenje z zdravilom Envarsus je treba začeti z odmerkom 0,17 mg/kg/dan enkrat na dan zjutraj.
English: - The active substance is tacrolimus.
Slovenian: - Učinkovina je takrolimus.
English: Factors such as low haematocrit and protein levels, which result in an increase in the unbound fraction of tacrolimus, or corticosteroid-induced increased metabolism, are considered to be responsible for the higher clearance rates observed following transplantation.
Slovenian: Velja, da so za višje stopnje očistka, ki so jih opazili po presaditvi, odgovorni dejavniki, kot so nizke ravni hematokrita in beljakovin, ki povzročijo povečanje nevezanih frakcij takrolimusa ali večjo presnovo zaradi kortikosteroida.
English: Blood trough levels of tacrolimus should also be closely monitored following conversion from tacrolimus products, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
Slovenian: Najnižje koncentracije takrolimusa v krvi je treba nadzirati tudi po prehodu z zdravila s takrolimusom, prilagoditvi odmerka, spremembah imunosupresivnega režima ali sočasni uporabi učinkovin, ki lahko spremenijo koncentracije takrolimusa v polni krvi
English: How long should I take the Envarsus tablets
Slovenian: Kako moram jemati tablete zdravila Envarsus
English: Inadvertent, unintentional, or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Slovenian: Nepazljiva, nenamerna ali nenadzorovana zamenjava farmacevtskih oblik takrolimusa s takojšnjim ali podaljšanim sproščanjem ni varna.
English: Therefore, you may be more prone to infections while you are taking Envarsus.
Slovenian: Morda boste zaradi tega med jemanjem zdravila Envarsus bolj nagnjeni k okužbam.
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: vendar pa podatki kažejo, da je imela večina novorojenčkov normalno telesno maso za svojo gestacijsko starost) ter za hiperkaliemijo pri novorojenčkih (incidenca 8 od 111 novorojenčkov, tj.
English: Patients treated with tacrolimus have been reported to develop Epstein-Barr Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s takrolimusom, so poročali o pojavu z Epstein-Barr virusom (EBV)
English: Envarsus contains the active substance tacrolimus presented in a prolonged release formulation.
Slovenian: Zdravilo Envarsus vsebuje učinkovino takrolimus v farmacevtski obliki s podaljšanim sproščanjem.
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Envarsus.
Slovenian: Med jemanjem zdravila Envarsus morate omejiti izpostavljenost sončni svetlobi in ultravijoličnim žarkom.
English: How to store Envarsus
Slovenian: Kako jemati zdravilo Envarsus
English: Nervous system disorders headache, tremor nervous system disorders seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language ab-normalities, paralysis and paresis, amnesia hypertonia myasthenia
Slovenian: motnje zavesti, periferne nevropatije, omotica, parestezije in dizestezije, motnje pri pisanju encefalopatija, krvavitve v osrednje živčevje in cerebrovaskularni incidenti, koma, motnje govora in izražanja, paraliza in pareza, amnezija hipertonija miastenija
English: Envarsus therapy should commence at a dose of 0.11-0.13 mg/kg/day administered once daily in the morning.
Slovenian: Profilaksa zavrnitve presajenih jeter Zdravljenje z zdravilom Envarsus je treba začeti z odmerkom 0,11 do 0,13 mg/kg/dan enkrat na dan zjutraj.
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm count and motility was observed in rats (see section 5.3).
Slovenian: Pri podganah je takrolimus negativno učinkoval na plodnost samcev; kazal se je z zmanjšanjem števila in gibljivosti spermijev (glejte poglavje 5.3).
English: Chiesi Hellas AEBE Τηλ: + 30 210 6179763
Slovenian: Τηλ: + 30 210 6179763
English: Ear and labyrinth disorders tinnitus hypoacusis deafness neurosensory hearing impaired
Slovenian: vključno z motnjami labirinta tinitus hipoakuzija nevrosenzo rična naglušnost okvara sluha
English: As in kidney transplant recipients, there appears to be no meaningful difference in the pattern of suspected adverse drug reactions between once daily Envarsus and tacrolimus immediate-release capsules (Prograf).
Slovenian: pri prejemnikih presajene ledvice ni značilne razlike v vzorcu neželenih učinkov, ki so domnevno povezani z zdravilom Envarsus enkrat na dan in kapsulami takrolimusa s takojšnjim sproščanjem (zdravilo Prograf).
English: Allograft transplant patients maintained on twice daily Prograf (immediate-release) or Advagraf (once daily) dosing requiring conversion to once daily Envarsus should be converted on a 1:0.7 (mg:mg)
Slovenian: Po alogenski presaditvi je treba pri bolnikih, pri katerih se vzdržuje odmerjanje zdravila Prograf dvakrat na dan (takojšnje sproščanje) ali zdravila Advagraf (enkrat na dan), in pri katerih je potreben prehod na zdravilo Envarsus enkrat na dan, prehod opraviti na osnovi skupnega dnevnega odmerka 1:0,7 (mg:mg), vzdrževalni odmerek zdravila Envarsus pa naj bo zato 30 % manjši od odmerka zdravila Prograf ali Advagraf.
English: Metabolism and nutrition disorders diabetes mellitus, hyperglycaemic conditions, hyperkalaemia anorexia, metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphateaemia dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia
Slovenian: hiperurikemija, hipomagneziemija, hipokaliemija, hipokalciemija, zmanjšanje apetita, hiperholesterolemija, hiperlipidemija, hipertrigliceridemija, hipofosfatemija dehidracija, hipoglikemija, hipoproteinemija, hiperfosfatemija
English: As tacrolimus is a substance with low clearance, adjustments to the dose regimen may take several days before steady state is achieved.
Slovenian: Ker je očistek takrolimusa majhen, lahko prilagajanje odmerka za vzpostavitev stanja dinamičnega ravnovesja traja več dni.
English: Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Slovenian: Opazili so napake pri uporabi zdravila, vključno z nepazljivo, nenamerno ali nenadzorovano zamenjavo farmacevtskih oblik takrolimusa s takojšnjim ali podaljšanim sproščanjem.
English: From time to time, your doctor may need to do blood, urine, heart, or eye tests, to set the right dose of Envarsus.
Slovenian: srca ali oči, da bo določil pravilni odmerek zdravila Envarsus.
English: Cardiac disorders ischaemic coronary artery disorders, tachycardia heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations pericardial effusion
Slovenian: ventrikularne aritmije in zastoji srca, supraventrikularne aritmije, kardiomiopatije, ventrikularna hipertrofija, palpitacije perikardialni izliv
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including tacrolimus.
Slovenian: Pri bolnikih, zdravljenih z imunosupresivi, vključno s takrolimusom, so poročali o primerih nefropatije, povezane z virusom BK, kot tudi progresivne multifokalne levkoencefalopatije (PML), povezane z virusom JC.
English: Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g. aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir, or aciclovir).
Slovenian: Te učinke lahko poveča sočasna uporaba takrolimusa in zdravil z nefrotoksičnimi ali nevrotoksičnimi učinki (kot so aminoglikozidi, zaviralci giraze, vankomicin, kotrimoksazol, nesteroidni antirevmatiki,
English: Tacrolimus is a low-clearance substance.
Slovenian: Izločanje Takrolimus je učinkovina z nizkim očistkom.
English: The treatment failure rate using the same composite end-point with centrally read BPAR was 1.9% in the Envarsus group and 3.7% in the Prograf group (95% confidence interval [6.51%, 2.31%]).
Slovenian: 1,9 % v skupini z zdravilom Envarsus in 3,7 % v skupini z zdravilom Prograf (95-odstotni interval zaupanja [-6,51 %; 2,31 %]).
English: Envarsus contains lactose
Slovenian: Zdravilo Envarsus vsebuje laktozo
English: While you take Envarsus your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease (e.g. amiloride, triamterene, or spironolactone), nonsteroidal anti-inflammatory substances (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes.
Slovenian: Zdravnik mora tudi vedeti, če med jemanjem zdravila Envarsus jemljete dodatke kalija ali nekatere diuretike, ki se uporabljajo za preprečevanje srčne odpovedi, za zdravljenje hipertenzije in bolezni ledvic (npr. amilorid, triamteren ali spironolakton), nesteroidna protivnetna zdravila (npr. ibuprofen), ki se uporabljajo za zdravljenje povišane telesne temperature, vnetja in bolečin, antikoagulante
English: This medicinal product should only be prescribed, and changes in immunosuppressive therapy be initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
Slovenian: Samo zdravniki, izkušeni v imunosupresivnem zdravljenju in vodenju bolnikov s presadki, smejo predpisovati to zdravilo in spreminjati imunosupresivno zdravljenje.
English: Envarsus 0.75 mg prolonged-release tablets are oval, white to off-white uncoated tablet, debossed with “0.75” on one side and “TCS” on the other side.
Slovenian: Zdravilo Envarsus 0,75 mg tablete s podaljšanim sproščanjem so ovalne, bele do belkaste, neobložene tablete, z vtisom "0.75" na eni strani in "TCS" na drugi strani.
English: During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations.
Slovenian: nevrološko stanje in stanje vida, koncentracijo glukoze na tešče, elektrolite (zlasti kalij), teste delovanja jeter in ledvic, hematološke parametre, koagulacijske vrednosti in koncentracijo beljakovin v plazmi.
English: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Slovenian: Preprečevanje zavrnitve presadka pri odraslih prejemnikih alogenskega presadka ledvic ali jeter.
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Envarsus.
Slovenian: Med AUC in najnižjimi koncentracijami v polni krvi v stanju dinamičnega ravnovesja obstaja močna korelacija za zdravilo Envarsus.
English: Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Slovenian: Redne krvne preiskave bodo potrebne tudi med nadaljevanjem zdravljenja zaradi preverjanja ustreznosti odmerka in morebitnega potrebnega prilagajanja.
English: Dose reduction may be necessary in patients with severe liver impairment in order to maintain the tacrolimus blood trough levels within the recommended target range.
Slovenian: Za ohranitev najmanjše koncentracije takrolimusa v krvi znotraj priporočenega ciljnega območja bo morda pri bolnikih s hudo okvaro jeter potrebno zmanjšanje odmerka.
English: Musculoskeletal and connective tissue disorders arthralgia, back pain, muscle cramps, pain in limb joint disorders mobility decreased
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva artralgija, bolečine v hrbtu, mišični krči, bolečine v okončini težave s sklepi zmanjšanje gibljivosti
English: Respiratory, thoracic and mediastinal disorders parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations respiratory failures, respiratory tract disorders, asthma acute respiratory distress syndrome
Slovenian: dispneja, plevralni izliv, kašelj, faringitis, zamašenost nosu in vnetja dihalna odpoved, bolezni dihal, astma akutni respiratorni distresni sindrom
English: Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole and nefazodone.
Slovenian: nifedipinom, nikardipinom, diltiazemom, verapamilom, amiodaronom, danazolom, etinilestradiolom, omeprazolom in nefazodonom.
English: The relationship between tacrolimus trough levels and systemic exposure (AUC0-24) is well correlated and is similar between the immediate-release formulation and Envarsus.
Slovenian: Razmerje med najnižjimi koncentracijami takrolimusa in sistemsko izpostavljenostjo (AUC0-24) korelira in je za obe farmacevtski obliki s takojšnjim sproščanjem in za zdravilo Envarsus podobno.
English: In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
Slovenian: Rasa Pri bolnikih črne rase bodo za dosego enakih najnižjih koncentracij morda potrebni višji odmerki takrolimusa kot pri belcih.
English: Your doctor will usually reduce your Envarsus dose once your condition has stabilised.
Slovenian: Ko se bo vaše stanje ustalilo, bo zdravnik odmerek zdravila Envarsus običajno zmanjšal.
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should, therefore, be avoided.
Slovenian: Opisano je, da grenivkin sok zveča koncentracijo takrolimusa v krvi, zato se je treba pitju grenivkinega soka izogibati.
English: Patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Slovenian: Infekcijske in parazitske bolezni Bolnike med zdravljenjem s takrolimusom pogosto bolj ogrožajo okužbe (virusne, bakterijske,
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus.
Slovenian: Čista aplazija rdečih krvnih celic Pri bolnikih, zdravljenih s takrolimusom, so poročali o primerih čiste aplazije rdečih krvnih celic
English: Magnesium stearate Tartaric acid (E334) Butylated hydroxytoluene (E321) Dimethicone 350
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi hipromeloza laktoza monohidrat makrogol 6000 poloksamer 188 magnezijev stearat vinska kislina (E334) butilirani hidroksitoluen (E321) dimetikon 350
English: Eye disorders eye disorders, vision blurred, photophobia cataract blindness optic neuropathy
Slovenian: zamegljen vid, fotofobija katarakta slepota nevropatija vidnega živca
English: Envarsus 0.75 mg prolonged-release tablets Envarsus 1 mg prolonged-release tablets Envarsus 4 mg prolonged-release tablets
Slovenian: Envarsus 0,75 mg tablete s podaljšanim sproščanjem Envarsus 1 mg tablete s podaljšanim sproščanjem Envarsus 4 mg tablete s podaljšanim sproščanjem
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating hepatic or renal function or neurological symptoms.
Slovenian: Ti dve okužbi sta pogosto povezani z visokim imunosupresivnim bremenom in lahko vodita v resna ali smrtna stanja.
English: Skin and subcutaneous tissue disorders rash, pruritus, alopecias, acne, sweating increased dermatitis, photosensitivity toxic epidermal necrolysis (Lyell's syndrome)
Slovenian: močnejše znojenje dermatitis, fotosenzibilnost toksična epidermalna nekroliza (Lyellov sindrom)
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).
Slovenian: Zato se je treba izogibati uživanju večjih količin kalija in uporabi diuretikov, ki varčujejo s kalijem (npr. amilorid, triamteren ali spironolakton) (glejte poglavje 4.4).
English: increased uric acid or lipids in the blood, decreased appetite, loss of appetite, increased acidity of the blood, other changes in the blood salts (seen in blood tests) - anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare,
Slovenian: - znižanje vrednosti magnezija, fosfatov, kalija, kalcija ali natrija v krvi, preobremenitev s tekočino, zvišanje vrednosti sečne kisline ali lipidov v krvi, zmanjšanje apetita, izguba apetita, zvečana kislost krvi, druge spremembe elektrolitov v krvi (vidno na krvnih preiskavah) - simptomi tesnobe, zmedenost in dezorientiranost, depresija, razpoloženjske spremembe, nočne more, halucinacije, duševne motnje
English: Benign and malignant tumours have been reported following Envarsus treatment.
Slovenian: Po zdravljenju z zdravilom Envarsus so poročali o pojavu benignih in malignih tumorjev.
English: High potassium intake or potassium-sparing diuretics should be avoided (see section 4.5).
Slovenian: Uživanju obilice kalija in uporabi diuretikov, ki varčujejo s kalijem, se je treba izogniti (glejte poglavje 4.5).
English: Symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
Slovenian: urtikarija, letargija, zvišanje dušika iz sečnine v krvi, povečanje koncentracije kreatinina v serumu in zvišanje ravni alanin-aminotransferaze.