FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandimmun treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Slovenian: Zdravljenje z zdravilom Sandimmun lahko uvede samo zdravnik, ki ima izkušnje z diagnostiko in zdravljenjem atopijskega dermatitisa.
English: The combination of Sandimmun with low doses of oral corticosteroids is recommended if the effect of Sandimmun alone is not satisfactory, especially in steroid-resistant patients.
Slovenian: Če samo z zdravilom Sandimmun ni mogoče doseči zadovoljivega učinka, ga je priporočeno uporabiti v kombinaciji z nizkimi odmerki peroralnih kortikosteroidov, zlasti pri bolnikih, ki so rezistentni na steroide.
English: For volume less than 1 ml or equal to 1 ml, use the 1-ml syringe.
Slovenian: Če morate odmeriti volumen, ki je manjši ali enak 1 ml, uporabite 1-mililitrsko brizgo.
English: Tear off the sealing ring completely.
Slovenian: V celoti odtrgajte tesnilni obroč.
English: For inducing remission, the recommended initial dose is 2.5 mg/kg/day orally given in 2 divided doses.
Slovenian: Za indukcijo remisije je priporočeni začetni odmerek 2,5 mg/kg/dan peroralno v dveh deljenih odmerkih.
English: Experience with Sandimmun in children with atopic dermatitis is limited.
Slovenian: Izkušenj z uporabo zdravila Sandimmun pri otrocih z atopijskim dermatitisom je malo.
English: In some patients, it may be difficult to detect Sandimmun-induced renal dysfunction because of changes in renal function related to the nephrotic syndrome itself.
Slovenian: Pri nekaterih bolnikih je zaradi sprememb delovanja ledvic v zvezi s samim nefrotskim sindromom težko zaznati okvaro delovanja ledvic, ki je posledica jemanja zdravila Sandimmun.
English: Nausea, vomiting, abdominal discomfort/pain, diarrhoea, gingival hyperplasia, peptic ulcer
Slovenian: Bolezni prebavil pogosti navzea, bruhanje, neprijeten občutek/bolečine v trebuhu, diareja, hiperplazija dlesni, peptični ulkus redki pankreatitis
English: In a few psoriatic patients treated with Sandimmun, lymphoproliferative disorders have occurred.
Slovenian: Pri nekaj bolnikih s psoriazo, zdravljenih z zdravilom Sandimmun, je prišlo do limfoproliferativnih bolezni, ki so se dobro odzvale na takojšnjo prekinitev zdravljenja.
English: If your doctor switches you from one oral formulation of ciclosporin to another After you change from one oral formulation of ciclosporin to another:
Slovenian: Če vam je zdravnik zamenjal eno peroralno obliko ciklosporina za drugo
English: If you have fructose intolerance, inform your doctor before taking this medicine, as it contains sorbitol.
Slovenian: Če imate intoleranco za fruktozo, pred začetkom jemanja zdravila o tem obvestite svojega zdravnik,
English: • Low level of red blood cells, low level of platelets in your blood which could increase the risk of bleeding.
Slovenian: • povečanje telesne mase • znižano število eritrocitov, znižano število trombocitov v krvi, kar lahko poveča možnost krvavitve
English: Ciclosporin is not dialysable to any great extent, nor is it well cleared by charcoal haemoperfusion.
Slovenian: Ciklosporina ni mogoče v večji meri odstraniti iz telesa niti z dializo niti s hemoperfuzijo preko aktivnega oglja.
English: Renal biopsy should be considered for patients with steroid-dependent minimal-change nephropathy, in whom Sandimmun therapy has been maintained for more than 1 year.
Slovenian: Zato je pri bolnikih z od kortikosteroidov odvisno nefropatijo z minimalnimi spremembami, ki so prejemali zdravilo Sandimmun več kot 1 leto, treba razmisliti o biopsiji ledvic.
English: Your doctor may give you magnesium supplements to take, especially just after your transplant operation.
Slovenian: Zdravnik vam bo morda svetoval uživanje nadomestkov z magnezijem, zlasti v obdobju takoj po operaciji presadka.
English: if you have high levels of potassium in your blood.
Slovenian: • če imate zvišano koncentracijo kalija v krvi.
English: The ethanol content of the Sandimmun formulations should also be taken into account in women who are breast-feeding (see section 4.4).
Slovenian: Treba je upoštevati tudi vsebnost etanola v formulaciji zdravila Sandimmun (glejte poglavje 4.4).
English: In patients with impaired renal function, the initial dose should not exceed 2.5 mg/kg/day.
Slovenian: Pri bolnikih z zmanjšano ledvično funkcijo začetni odmerek ne sme preseči 2,5 mg/kg/dan.
English: Sandimmun may also cause dose-dependent, reversible increases in serum bilirubin and in liver enzymes (see section 4.8).
Slovenian: Med dolgotrajnim zdravljenjem lahko zdravilo Sandimmun povzroči tudi od odmerka odvisno reverzibilno zvišanje koncentracije bilirubina in jetrnih encimov (glejte poglavje 4.8).
English: In nephrotic syndrome patients with impaired renal function, the initial dose should not exceed 2.5 mg/kg/day.
Slovenian: Pri bolnikih z nefrotskim sindromom in zmanjšano ledvično funkcijo začetni odmerek ne sme presegati 2,5 mg/kg/dan.
English: No data exist on the effects of Sandimmun on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji O vplivu zdravila Sandimmun na sposobnost vožnje in upravljanja s stroji ni nobenih podatkov.
English: This is because this medicine contains alcohol (see section below “Sandimmun conatins castor oil and ethanol”).
Slovenian: To je pomembno zato, ker zdravilo vsebuje alkohol (glejte poglavje v nadaljevanju “Zdravilo Sandimmun vsebuje makrogolglicerol ricinolat in etanol”).
English: This is divided into two doses.
Slovenian: Dnevni odmerek je treba razdeliti na dva odmerka.
English: If any of the above applies to you before or during treatment with Sandimmun, tell your doctor straight away.
Slovenian: Če pred začetkom zdravljenja ali v času zdravljenja z zdravilom Sandimmun pride do katere od zgoraj navedenih težav, takoj obvestite zdravnika.
English: - Then, put the syringe back in its cover.
Slovenian: Brizgo nato spravite nazaj v tulec.
English: Occasional monitoring of ciclosporin blood levels may be relevant in non-transplant indications, e.g. when Sandimmun is co-administered with substances that may interfere with the pharmacokinetics of ciclosporin, or in the event of unusual clinical response (e.g. lack of efficacy or increased drug intolerance such as renal dysfunction).
Slovenian: Občasno spremljanje koncentracije ciklosporina v krvi je lahko smiselno pri bolnikih, ki prejemajo zdravilo Sandimmun zaradi indikacij, ki niso povezane s presaditvijo, kadar ga na primer prejemajo sočasno z učinkovinami, ki lahko vplivajo na farmakokinetiko ciklosporina, ali v primeru neobičajnega kliničnega odziva (na primer neučinkovitosti zdravila ali povečane intolerance za zdravilo, kot je ledvična disfunkcija).
English: Sandimmun 100 mg/ml oral solution ciclosporin
Slovenian: Navodilo za uporabo Sandimmun 100 mg/ml peroralna raztopina ciklosporin
English: - Leave the white stopper and tube in the bottle.
Slovenian: Bel čep s potopno cevko pustite v steklenici.
English: The recommended dose range is 2.5 to 5 mg/kg/day given in 2 divided oral doses.
Slovenian: Priporočeno je odmerjanje v okviru od 2,5 do 5 mg/kg/dan v dveh deljenih peroralnih odmerkih.
English: Barbiturates, carbamazepine, oxcarbazepine, phenytoin; nafcillin, intravenous sulfadimidine, probucol, orlistat, hypericum perforatum (St. John's wort), ticlopidine, sulfinpyrazone, terbinafine, bosentan.
Slovenian: Primeri zdravil, ki znižujejo koncentracijo ciklosporina, so: barbiturati, karbamazepin, okskarbazepin, fenitoin, nafcilin, intravenski sulfadimidin, probukol, orlistat, Hypericum perforatum (šentjanževka), tiklopidin, sulfinpirazon, terbinafin in bosentan.
English: Non-transplantation indications
Slovenian: Indikacije, ki niso povezane s presaditvijo
English: Sandimmun oral solution contains 12.6% v/v ethanol (10.0% m/v ethanol).
Slovenian: Sandimmun peroralna raztopina vsebuje 12,6 % volumskega deleža etanola (kar je 10,0 % masnega deleža).
English: This is normal and does not mean that there is anything wrong with the capsules.
Slovenian: Značilni vonj, ki se pojavi pri odpiranju pretisnega omota, je normalen in ne pomeni, da bi bilo kaj narobe s kapsulami.
English: If you have been prescribed Sandimmun to treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during treatment.
Slovenian: Če se z zdravilom Sandimmun zdravite zaradi luskavice ali atopijskega dermatitisa, se hkrati ne smete zdraviti z ultravijoličnimi žarki B (UVB) ali s fototerapijo.
English: • High level of lipids in your blood.
Slovenian: • zvišana raven lipidov v krvi
English: Except for the treatment of nephrotic syndrome, there is no adequate experience available with Sandimmun.
Slovenian: Uporaba pri otrocih za indikacije, ki niso povezane s presaditvami Razen pri zdravljenju nefrotskega sindroma ni na voljo zadostnih izkušenj z zdravilom Sandimmun.
English: Sandimmun 50 mg soft capsules are corn yellow and oblong.
Slovenian: Sandimmun 50 mg mehke kapsule so koruzno rumene barve in podolgovate oblike.
English: If you are taking Sandimmun following a transplant it will only be prescribed for you by a doctor with experience in transplants and/or autoimmune diseases.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Sandimmun Če prejemate zdravilo Sandimmun zaradi presaditve, vam ga lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem pri presaditvah in/ali avtoimunskih boleznih.
English: Concomitant use of ciclosporin and tacrolimus should be avoided due to the risk for nephrotoxicity and pharmacokinetic interaction via CYP3A4 and/or P-gp (see section 4.4).
Slovenian: Sočasni uporabi ciklosporina in takrolimusa se je treba izogibati, ker obstaja tveganje za toksično delovanje na ledvice in za farmakokinetične interakcije, ki vključujejo CYP3A4 in/ali P-glikoprotein
English: Treatment should be discontinued in patients in whom sufficient response of psoriatic lesions cannot be achieved within 6 weeks on 5 mg/kg/day, or in whom the effective dose is not compatible with the established safety guidelines (see section 4.4).
Slovenian: Če po 6 tednih zdravljenja z odmerkom 5 mg/kg/dan ne pride do zadostnega odziva psoriatičnih lezij ali če učinkoviti odmerek ne ustreza uveljavljenim varnostnim smernicam, je treba zdravljenje prekiniti (glejte poglavje 4.4).
English: Caution should be observed while co-administering ciclosporin with such drugs or concomitant use should be avoided (see section 4.5).
Slovenian: Pri sočasnem dajanju takih zdravil in ciklosporina je potrebna previdnost ali pa se je sočasni uporabi z njimi treba povsem izogniti (glejte poglavje 4.5).
English: Nicardipine, metoclopramide, oral contraceptives, methylprednisolone (high dose), allopurinol, cholic acid and derivatives, protease inhibitors, imatinib, colchicine, nefazodone.
Slovenian: nikardipin, metoklopramid; peroralni kontraceptivi; metilprednizolon (v visokih odmerkih); alopurinol; holna kislina in njeni derivati; zaviralci proteaze; imatinib; kolhicin, nefazodon.
English: Your doctor will adjust your dose to one that is ideal for you.
Slovenian: Vaš zdravnik vam bo odmerek prilagodil tako, da bo za vas kar najbolj primeren.
English: For maintenance treatment the dose has to be titrated individually to the lowest effective level according to tolerability.
Slovenian: Za vzdrževalno zdravljenje je treba odmerek pri vsakem posameznem bolniku titrirati do najnižje še učinkovite ravni glede na to, kako bolnik prenaša zdravilo.
English: • The other ingredients are: ethanol anhydrous, macrogolglycerol ricinolate/polyethoxynolated castor oil.
Slovenian: • Druge sestavine zdravila so: brezvodni etanol, makrogolglicerol ricinolat.
English: Sandimmun and associated names (see Annex I) 25 mg soft capsules Sandimmun and associated names (see Annex I) 50 mg soft capsules Sandimmun and associated names (see Annex I) 100 mg soft capsules [See Annex I - To be completed nationally]
Slovenian: Sandimmun in povezana imena (glejte Prilogo I) 25 mg mehke kapsule Sandimmun in povezana imena (glejte Prilogo I) 50 mg mehke kapsule Sandimmun in povezana imena (glejte Prilogo I) 100 mg mehke kapsule [glejte Prilogo I - izpolni država članica]
English: Ethanol: 25 mg/capsule.
Slovenian: Etanol: 25 mg na kapsulo.
English: To achieve initial remission, or to counteract inflammatory ocular attacks, systemic corticosteroid treatment with daily doses of 0.2 to 0.6 mg/kg prednisone or an equivalent may be added if Sandimmun alone does not control the situation sufficiently.
Slovenian: Če samo z zdravilom Sandimmun ni mogoče umiriti vnetja v zadostni meri, je mogoče za doseganje začetne remisije ali za preprečevanje napadov očesnega vnetja dodati sistemske kortikosteroide, in sicer od 0,2 do 0,6 mg/kg prednizona dnevno ali enakovreden odmerek drugega ustreznega zdravila.
English: - For more than 1 ml of medicine, use the 4 ml syringe.
Slovenian: Za več kot 1 ml zdravila uporabite 4-mililitrsko brizgo.
English: In 9 liver transplant patients aged 0.65-6 years, clearance was 9.3±5.4 ml/min/kg (assay: HPLC).
Slovenian: starih 0,65-6 let, je očistek znašal 9,3±5,4 ml/min/kg (analizna metoda: tekočinska kromatografija visoke ločljivosti, angl. high-performance liquid chromatography - HPLC).
English: What Sandimmun is used for and how it works Sandimmun is used to control the body's immune system following an organ transplant, including bone marrow and stem cell transplantation.
Slovenian: Za kaj uporabljamo zdravilo Sandimmun in kako deluje Zdravilo Sandimmun uporabljamo za zaviranje imunskega sistema v telesu po presaditvi organa,
English: METHOD OF ADMINISTRATION [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [izpolni država članica]
English: Sandimmun should only be prescribed by, or in close collaboration with, a physician with experience of immunosuppressive therapy and/or organ transplantation.
Slovenian: Zdravljenje z zdravilom Sandimmun lahko predpiše samo zdravnik, ki ima izkušnje z imunosupresivnim zdravljenjem in/ali presaditvijo organov, oziroma zdravnik v tesnem sodelovanju z izkušenim zdravnikom.
English: Statin therapy needs to be temporarily withheld or discontinued in patients with signs and symptoms of myopathy or those with risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis (see section
Slovenian: Zdravljenje s statini je treba začasno ali dokončno prekiniti pri bolnikih z znaki in simptomi miopatije in pri tistih z dejavniki tveganja, ki povečujejo dovzetnost za hudo ledvično okvaro, vključno z ledvično odpovedjo zaradi rabdomiolize (glejte poglavje 4.5).
English: Skin lesions not typical for psoriasis, but suspected to be malignant or pre-malignant should be biopsied before Sandimmun treatment is started.
Slovenian: V primeru kožne spremembe, ki ni značilna za psoriazo, obstaja pa sum na maligno bolezen ali predstopnjo malignega obolenja, je treba opraviti biopsijo pred začetkom zdravljenja z zdravilom
English: Polyethoxylated castor oil and anaphylactoid reactions Sandimmun concentrate for solution for infusion contains polyethoxylated castor oil, which has been reported to cause anaphylactoid reactions following intravenous administration.
Slovenian: Makrogolglicerol ricinolat in anafilaktoidne reakcije Sandimmun koncentrat za raztopino za infundiranje vsebuje makrogolglicerol ricinolat, za katerega so poročali, da po intravenskem odmerjanju povzroča anafilaktoidne reakcije.
English: Sandimmun 100 mg soft capsules are dusty rose and oblong.
Slovenian: Sandimmun 100 mg mehke kapsule so zamolklo rožnate barve in podolgovate oblike.
English: Signs of infection might be fever or sore throat.
Slovenian: • če imate znake okužbe, kot sta zvišana telesna temperatura ali vneto grlo oziroma žrelo.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA [izpolni država članica]
English: Do not take more than the recommended dose.
Slovenian: Ne jemljite višjih odmerkov zdravila, kot vam jih predpiše zdravnik.
English: The concentrate for solution for infusion should be diluted 1:20 to 1:100 with normal saline or 5% glucose and given as a slow intravenous infusion over 2 to 6 hours.
Slovenian: Koncentrat za raztopino za infundiranje je treba razredčiti v fiziološki raztopini ali v 5-odstotni raztopini glukoze v razmerju 1:20 do 1:100 in aplicirati s počasno intravensko infuzijo, ki traja od 2
English: • Gum tissue overgrowing and covering your teeth.
Slovenian: • preraščanje tkiva dlesni preko zob
English: Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and/or life-threatening events, e.g. bosentan, dabigatran etexilate and aliskiren (see section 4.5).
Slovenian: Kombinacija z zdravili, kot so bosentan, dabigatran eteksilat in aliskiren, ki so substrati efluksnega prenašalca za več zdravil P-glikoproteina ali organskega anionskega prenašalnega polipeptida (angl. organic anion-transporting polypeptide - OATP) in zaradi katerih lahko zvišana koncentracija v plazmi povzroči resne in/ali smrtno nevarne zaplete (glejte poglavje 4.5).
English: Bone marrow transplantation Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation.
Slovenian: Preprečevanje zavrnitve presadka po alogeni presaditvi kostnega mozga in matičnih celic.
English: Your dose may need to be changed.
Slovenian: Morda vam bo moral zdravnik znižati odmerek.
English: The normal route of administration is by mouth.
Slovenian: Normalen način odmerjanja je peroralen.
English: The dose of this medicine will be carefully adjusted to your individual needs by your doctor.
Slovenian: Vaš zdravnik bo prilagodil odmerek zdravila glede na vaše potrebe.
English: - with products containing dabigatran etexilate (used to avoid blood clots after surgery) or bosentan and aliskiren (used to reduce high blood pressure).
Slovenian: skupaj s pripravki, ki vsebujejo Hypericum perforatum (šentjanževko); skupaj s pripravki, ki vsebujejo dabigatran eteksilat (za preprečevanje nastajanja krvnih strdkov po operaciji) ali bosentan in aliskiren (za zniževanje visokega krvnega tlaka).
English: It may also affect your sight because of the higher pressure inside your head (benign intracranial hypertension).
Slovenian: • otekanje zadajšnjega dela očesa, ki je lahko povezano z zamegljenim vidom, in možnost okvare vida zaradi povečanega pritiska v glavi (benigna intrakranialna hipertenzija);
English: In addition if you are taking Sandimmun for a non-transplant disease (intermediary or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Sandimmun:
Slovenian: (zaradi intermediarnega ali zadajšnjega uveitisa in Behcetovega uveitisa, atopijskega dermatitisa, hude oblike revmatoidnega artritisa ali zaradi nefrotskega sindroma), ne smete jemati zdravila Sandimmun:
English: For maintenance treatment the lowest effective and well tolerated dosage should be determined individually.
Slovenian: Za vzdrževalno zdravljenje je treba pri vsakem bolniku posebej določiti najnižji odmerek, ki je učinkovit in ga bolnik dobro prenaša.
English: • Tell your doctor if you are breast-feeding.
Slovenian: • Zdravniku povejte, če dojite.
English: Ciclosporin doses may need to be increased 3- to 5-fold during co-administration.
Slovenian: V obdobju sočasne uporabe je včasih treba 3 do 5-krat zvišati odmerek ciklosporina.
English: The concentrate is used to prepare a solution which is administered by intravenous infusion.
Slovenian: Koncentrat uporabimo za pripravljanje raztopine, ki jo bolniku odmerimo z intravensko infuzijo.
English: Avoid any contact between the syringe and the liquid in the glass.
Slovenian: Pazite, da se z brizgo pri tem ne dotaknete tekočine v kozarcu.
English: Before initiation of treatment a reliable baseline assessment of renal function should be established by at least two measurements of eGFR.
Slovenian: Pred začetkom zdravljenja je treba določiti zanesljivo vrednost izhodiščne stopnje ledvične funkcije z najmanj dvema meritvama ocenjene hitrosti glomerulne filtracije.
English: Intravenous use
Slovenian: Način uporabe intravenska uporaba
English: Anaphylactoid reactions have been observed following intravenous administration (see section 4.4).
Slovenian: Po intravenskem odmerjanju zdravila so opažali anafilaktoidne reakcije (glejte poglavje 4.4).
English: What Sandimmun is used for and how Sandimmun works
Slovenian: Za kaj uporabljamo zdravilo Sandimmun in kako deluje
English: • Nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhoea.
Slovenian: • navzea (občutek slabosti), bruhanje, bolečine v trebuhu, zaprtje, driska
English: • Changes in your sight, loss of coordination, being clumsy, memory loss, difficulty speaking or understanding what others say, and muscle weakness.
Slovenian: • če opazite spremembe vida, če svojih gibov ne morete več usklajevati, če postanete nerodni, se vam slabša spomin, če težko govorite ali težko razumete, kar govorijo drugi, ali če vam oslabijo mišice, so to lahko znaki in simptomi možganske okužbe, ki jo imenujemo progresivna multifokalna levkoencefalopatija;
English: Discontinuation of Sandimmun may also become necessary if hypertension developing during treatment cannot be controlled by appropriate therapy.
Slovenian: Prekinitev zdravljenja z zdravilom Sandimmun je lahko potrebna tudi v primeru, da med zdravljenjem pride do hipertenzije, ki je z ustreznimi zdravili ni mogoče urediti.
English: • Like other medicines that act on the immune system, ciclosporin may influence your body's ability to fight against infection and may cause tumours or other cancers, particularly of the skin.
Slovenian: • kot druga zdravila, ki zavirajo imunski sistem, lahko tudi ciklosporin ovira sposobnost telesa,
English: Each ampoule of 5 ml contains 250 mg of ciclosporin.
Slovenian: Ena 5-mililitrska ampula vsebuje 250 mg ciklosporina.
English: - The lower part of the plunger ring needs to be in front of the mark on the syringe which shows the amount of medicine.
Slovenian: Spodnji del bata mora biti poravnan z oznako na brizgi,
English: Other adverse drug reactions from post-marketing experience There have been solicited and spontaneous reports of hepatotoxicity and liver injury including cholestasis, jaundice hepatitis and liver failure in patients treated with ciclosporin.
Slovenian: Drugi neželeni učinki zdravila iz izkušenj v obdobju trženja zdravila Pri bolnikih, ki so prejemali ciklosporin, obstajajo sistematično zbrana in spontana poročila o toksičnem delovanju na jetra in okvarah jeter, vključno s holestazo, z ikterusom, s hepatitisom in z odpovedjo jeter.
English: Choose the syringe depending on the prescribed volume.
Slovenian: Glede na višino predpisanega odmerka izberite brizgo za odmerjanje.
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution containing 100 mg ciclosporin per mL
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Peroralna raztopina vsebuje 100 mg ciklosporina na ml.
English: Combinations with increased risk for nephrotoxicity Care should be taken when using ciclosporin together with other active substances that exhibit nephrotoxic synergy such as: aminoglycosides (including gentamycin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole); fibric acid derivatives (e.g. bezafibrate, fenofibrate); NSAIDs (including diclofenac, naproxen, sulindac); melphalan histamine H2-receptor antagonists (e.g. cimetidine, ranitidine); methotrexate (see section 4.4).
Slovenian: Kombinacije s povečanim tveganjem za toksično delovanje na ledvice Previdnost je potrebna pri sočasni uporabi zdravil, ki bi lahko povzročala sinergistično toksično delovanje na ledvice, kot so: aminoglikozidi (vključno z gentamicinom in s tobramicinom), amfotericin B, ciprofloksacin, vankomicin, trimetoprim (s sulfometoksazolom); derivati fibrične kisline (na primer bezafibrat, fenofibrat); nesteroidna protivnetna zdravila (vključno z diklofenakom, naproksenom in sulindakom); melfalan, antagonisti histaminskih receptorjev H2 (na primer cimetidin in ranitidin); metotreksat (glejte poglavje 4.4).