FrancophonIA/ELRC3.0 huggingface dataset:
English: No dosage adjustment of posaconazole tablets is required when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Slovenian: Med sočasno uporabo tablet posakonazola in antacidov, antagonistov receptorjev H2 in zaviralcev protonske črpalke prilagoditev odmerka tablet posakonazola ni potrebna.
English: If you become pregnant while you are taking Noxafil, contact your doctor straight away.
Slovenian: Če med jemanjem zdravila Noxafil zanosite, se nemudoma posvetujte z zdravnikom.
English: What Noxafil contains The active substance in Noxafil is posaconazole.
Slovenian: Kaj vsebuje zdravilo Noxafil Učinkovina v zdravilu Noxafil je posakonazol.
English: Do not take Noxafil if any of the above apply to you.
Slovenian: Ne vzemite zdravila Noxafil, če kaj od naštetega velja za vas.
English: Gender The pharmacokinetics of posaconazole are comparable in men and women.
Slovenian: Spol Farmakokinetika posakonazola je pri moških in ženskah primerljiva.
English: • have heart rhythm disturbance
Slovenian: • če imate kakšno motnjo srčnega ritma.
English: How to take Noxafil
Slovenian: Kako jemati zdravilo Noxafil
English: If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Noxafil, kot bi smeli Če vas skrbi, da ste morda zaužili preveč zdravila, nemudoma pokličite zdravnika ali zdravstvenega delavca.
English: Frequent monitoring for adverse reactions and toxicity related to calcium channel blockers is recommended during co-administration with posaconazole.
Slovenian: Med sočasno uporabo s posakonazolom je priporočljivo pogosto spremljanje glede neželenih učinkov in toksičnosti, povezanih z zaviralci kalcijevih kanalčkov.
English: Each ml of oral suspension contains 40 mg of posaconazole.
Slovenian: En ml peroralne suspenzije vsebuje 40 mg posakonazola.
English: Discontinuation of Noxafil should be considered if clinical signs and symptoms are consistent with development of liver disease.
Slovenian: Če klinični znaki in simptomi kažejo na razvoj jetrne bolezni, je treba po potrebi prekiniti zdravljenje z zdravilom Noxafil.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
Slovenian: V farmakološki študiji varnosti ponavljajočih se odmerkov ehokardiografija pri podganah ni pokazala znakov srčne dekompenzacije pri sistemski izpostavljenosti, ki je bila 1,4-krat večja od terapevtsko dosežene.
English: • if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin”
Slovenian: • če jemljete: terfenadin, astemizol, cisaprid, pimozid, halofantrin, kinidin, katero koli zdravilo,
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.9-fold greater than the concentrations obtained at therapeutic doses in humans with 300 mg intravenous infusion administration.
Slovenian: V farmakološki študiji varnosti ponavljajočih se odmerkov na opicah pri največjih koncentracijah v plazmi, ki so bile 8,9-krat večje od koncentracij, doseženih med uporabo terapevtskih odmerkov pri človeku z uporabo 300 mg počasne intravenske infuzije, na elektrokardiogramih (vključno z intervaloma QT in QTc) niso opazili nobenih učinkov.
English: • low potassium levels - shown up in blood tests
Slovenian: • nizka koncentracija kalija - pokaže se na preiskavah krvi
English: Posaconazole exhibits dose proportional pharmacokinetics after single and multiple dosing in the therapeutic dose range (200-300 mg).
Slovenian: Farmakokinetika posakonazola je v območju terapevtskih odmerkov (od 200 do 300 mg) sorazmerna odmerku tako po enkratnem kot po večkratnem odmerjanju.
English: Neuronal phospholipidosis occurred in dogs dosed for  3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Slovenian: Pri psih, ki so  3 mesece dobivali odmerke zdravila za manjšo sistemsko izpostavljenost od tiste, dosežene med uporabo terapevtskih odmerkov pri človeku, se je pojavila fosfolipidoza nevronov.
English: • cough, hiccups
Slovenian: • kašelj, kolcanje
English: Noxafil 300 mg sterile concentrate posaconazole
Slovenian: Noxafil 300 mg sterilen koncentrat posakonazol intravenska uporaba po razredčenju
English: In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
Slovenian: V drugi študiji pri zdravih prostovoljcih je uporaba večkratnih odmerkov peroralne suspenzije posakonazola (200 mg dvakrat na dan 7 dni) povečala Cmax intravensko uporabljenega midazolama (enkratni odmerek 0,4 mg) v povprečju za 1,3-krat, njegovo AUC pa za 4,6-krat (razpon od 1,7-krat do 6,4-krat).
English: There was a slight decrease (16 %) in the AUC and Cmax of posaconazole oral suspension in Black subjects relative to Caucasian subjects.
Slovenian: Pri preiskovancih črne rase so v primerjavi s preiskovanci bele rase ugotovili malenkost manjši (16 %) AUC in Cmax posakonazola v peroralni suspenziji.
English: • feeling bloated
Slovenian: • občutek napihnjenosti
English: Plasma concentrations following administration of posaconazole intravenous concentrate for solution for infusion are generally higher than those obtained with posaconazole oral suspension.
Slovenian: Koncentracije posakonazola v plazmi so po uporabi posakonazola v koncentratu za raztopino za infundiranje običajno večje kot po uporabi peroralne suspenzije.
English: After the first day, take 100 mg (2.5 mL) once a day.
Slovenian: Potem jemljite po 100 mg (2,5 ml) enkrat na dan.
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold), respectively.
Slovenian: Po 7-dnevni sočasni uporabi peroralne suspenzije posakonazola (400 mg dvakrat na dan) z atazanavirjem (300 mg enkrat na dan) se je pri zdravih preiskovancih Cmax atazanavirja povečala v povprečju za 2,6-krat, njegova AUC pa za 3,7-krat (razpon od 1,2-krat do 26-krat).
English: Noxafil contains sodium
Slovenian: Zdravilo Noxafil vsebuje natrij
English: Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the st day, 200 mg twice daily on the 2
Slovenian: Pri uporabi ponavljajočih se odmerkov fosamprenavirja (700 mg dvakrat na dan 10 dni) sta se Cmax in AUC posakonazola v obliki peroralne suspenzije (200 mg enkrat na dan prvi dan, 200 mg dvakrat na dan drugi dan, nato 400 mg dvakrat na dan 8 dni) zmanjšali za 21 % oz. 23 %.
English: Based on average Cmin concentrations, a predicted average concentration (Cav) could be calculated for 186 subjects dosed with 300 mg. PK analysis in patients of Cav found that 81 % of the subjects treated with the 300 mg once daily dose attained steady state predicted Cav between 500-2,500 ng/mL.
Slovenian: Farmakokinetična analiza pri bolnikih s Cav je pokazala, da je 81 % preiskovancev, zdravljenih z odmerkom 300 mg enkrat na dan, doseglo predvideno Cav v stanju dinamičnega ravnovesja od 500 do 2.500 ng/ml.
English: Noxafil concentrate for solution for infusion should not be used in children aged below 18 years because of pre-clinical safety concerns (see section 5.3).
Slovenian: Zaradi predkliničnih zadržkov v zvezi z varnostjo (glejte poglavje 5.3) se zdravila Noxafil koncentrat za raztopino za infundiranje ne sme uporabljati pri otrocih, mlajših od 18 let.
English: Repeat dose administration of oral posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Slovenian: Uporaba večkratnih odmerkov posakonazola v obliki peroralne suspenzije (400 mg dvakrat na dan 16 dni) je pri zdravih osebah (ki so dobile enkraten odmerek 2 mg sirolimusa) povečala Cmax sirolimusa v povprečju za 6,7-krat in AUC sirolimusa v povprečju za 8,9-krat (razpon od 3,1-krat do 17,5-krat).
English: Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products; - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.
Slovenian: Zdravilo Noxafil peroralna suspenzija je indicirano za zdravljenje naslednjih glivnih okužb pri odraslih (glejte poglavje 5.1): - invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B ali itrakonazol, ter pri bolnikih, ki ne prenašajo teh zdravil, - fuzarioze pri bolnikih z okužbo, odporno na amfotericin B, ter pri bolnikih, ki ne prenašajo amfotericina B, - kromoblastomikoze in micetoma pri bolnikih z okužbo, odporno na itrakonazol, ter pri bolnikih, ki ne prenašajo itrakonazola, - kokcidioidomikoze pri bolnikih z okužbo, odporno na amfotericin B, itrakonazol ali flukonazol, ter pri bolnikih, ki ne prenašajo teh zdravil, - orofaringealne kandidoze: kot terapija prve izbire pri bolnikih s hudo okužbo ali pri tistih z imunsko pomanjkljivostjo, pri katerih pričakujemo, da bo odziv na topikalno terapijo slab.
English: Oropharyngeal candidiasis
Slovenian: Orofaringealna kandidoza
English: Each millilitre of oral suspension contains 40 milligrams of posaconazole.
Slovenian: En mililiter peroralne suspenzije vsebuje 40 miligramov posakonazola.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.2-fold greater than that achieved therapeutically.
Slovenian: V farmakološki študiji varnosti ponavljajočih se odmerkov ehokardiografija pri podganah ni pokazala znakov srčne dekompenzacije pri sistemski izpostavljenosti, ki je bila 2,2-krat večja od terapevtsko dosežene.
English: • belching
Slovenian: • srbenje
English: Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Slovenian: Zdravilo Noxafil koncentrat za raztopino za infundiranje je indicirano za zdravljenje naslednjih glivnih okužb pri odraslih (glejte poglavje 5.1): - invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B ali itrakonazol, ter pri bolnikih, ki ne prenašajo teh zdravil, - fuzarioze pri bolnikih z okužbo, odporno na amfotericin B, ter pri bolnikih, ki ne prenašajo amfotericina B, - kromoblastomikoze in micetoma pri bolnikih z okužbo, odporno na itrakonazol, ter pri bolnikih,
English: Hepatic reactions (e.g. elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Slovenian: Med zdravljenjem s posakonazolom so poročali o učinkih na jetra (npr. zvišanje ALT, AST, alkalne fosfataze, celokupnega bilirubina in/ali klinični hepatitis).
English: Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Slovenian: Zdravilo Noxafil gastrorezistentne tablete je indicirano tudi za profilakso invazivnih glivnih okužb pri: - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS) in pri katerih se zato pričakuje dolgotrajnejša nevtropenija ter imajo veliko tveganje za invazivne glivne okužbe, - prejemnikih presajenih hematopoetskih matičnih celic (HSCT), ki zaradi preprečevanja reakcije presadka proti gostitelju prejemajo visokoodmerno imunosupresivno zdravljenje in pri katerih obstaja veliko tveganje za invazivne glivne okužbe.
English: Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Slovenian: Zdravilo Noxafil gastrorezistentne tablete je indicirano za zdravljenje naslednjih glivnih okužb pri odraslih (glejte poglavje 5.1): - invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B ali itrakonazol, ter pri bolnikih, ki ne prenašajo teh zdravil, - fuzarioze pri bolnikih z okužbo, odporno na amfotericin B, ter pri bolnikih, ki ne prenašajo amfotericina B, - kromoblastomikoze in micetoma pri bolnikih z okužbo, odporno na itrakonazol, ter pri bolnikih,
English: Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Slovenian: Zdravilo Noxafil peroralna suspenzija je indicirano tudi za profilakso invazivnih glivnih okužb pri: - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS) in pri katerih se zato pričakuje dolgotrajnejša nevtropenija ter imajo veliko tveganje za invazivne glivne okužbe, - prejemnikih presajenih hematopoetskih matičnih celic (HSCT), ki zaradi preprečevanja reakcije presadka proti gostitelju prejemajo visokoodmerno imunosupresivno zdravljenje in pri katerih obstaja veliko tveganje za invazivne glivne okužbe.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.1-fold greater than that achieved therapeutically.
Slovenian: V farmakološki študiji varnosti ponavljajočih se odmerkov ehokardiografija pri podganah ni pokazala znakov srčne dekompenzacije pri sistemski izpostavljenosti, ki je bila 2,1-krat večja od terapevtsko dosežene.
English: What Noxafil contains
Slovenian: Kaj vsebuje zdravilo Noxafil
English: Effects of posaconazole on other medicinal products Posaconazole is a potent inhibitor of CYP3A4.
Slovenian: Posakonazol je močan zaviralec CYP3A4.
English: Do not breast-feed while taking Noxafil.
Slovenian: Med jemanjem zdravila Noxafil ne dojite.
English: Hydrochloric acid [for pH adjustment] Sodium hydroxide [for pH adjustment] Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev sulfobutileter betaciklodekstrin (SBECD) dinatrijev edetat klorovodikova kislina [za prilagoditev pH] natrijev hidroksid [za prilagoditev pH] voda za injekcije
English: Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole oral suspension (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Slovenian: 173 zdravim prostovoljcem in prostovoljkam, starim od 18 do 85 let, so v 12-urnem obdobju posneli več časovno usklajenih EKG, in sicer pred in med uporabo peroralne suspenzije posakonazola (400 mg dvakrat na dan, zaužite z zelo mastno hrano).
English: There were no neurologic, behavioural or developmental abnormalities in the dogs with this finding, and a similar brain finding was not seen with oral posaconazole administration to juvenile dogs (4 days to 9 months of age).
Slovenian: Podobne spremembe niso ugotovili med peroralno uporabo posakonazola pri juvenilnih psih (starih od 4 dni do 9 mesecev).
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.5-fold greater than the concentrations obtained at therapeutic doses in humans.
Slovenian: V farmakološki študiji varnosti ponavljajočih se odmerkov na opicah pri največjih koncentracijah v plazmi, ki so bile 8,5-krat večje od koncentracij, doseženih med uporabo terapevtskih odmerkov pri človeku, na elektrokardiogramih (vključno z intervaloma QT in QTc) niso opazili nobenih učinkov.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Noxafil.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete uporabljati zdravilo Noxafil.
English: Race There is insufficient data among different races with posaconazole tablets.
Slovenian: Rasa O uporabi tablet posakonazola pri različnih rasah ni dovolj podatkov.
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the concentrations obtained at therapeutic doses in humans.
Slovenian: V farmakološki študiji varnosti ponavljajočih se odmerkov na opicah pri sistemskih izpostavljenostih, ki so bile 4,6-krat večje od koncentracij, doseženih med uporabo terapevtskih odmerkov pri človeku, na elektrokardiogramih (vključno z intervaloma QT in QTc) niso opazili nobenih učinkov.
English: Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Če opazite katerega koli od naslednjih resnih neželenih učinkov, se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, kajti morda boste potrebovali nujno medicinsko pomoč:
English: Posaconazole plasma concentrations following administration of posaconazole may increase over time in some patients (see section 5.2).
Slovenian: Pri nekaterih bolnikih se lahko koncentracija posakonazola v plazmi po njegovi uporabi sčasoma poveča (glejte poglavje 5.2).
English: Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial (Study 0041).
Slovenian: V neprimerjalnem preskušanju (študija 0041) zadnje možnosti zdravljenja so za zdravljenje invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B (vključno z liposomskimi oblikami) ali itrakonazol, oziroma pri bolnikih, ki niso prenašali teh zdravil, ovrednotili peroralno suspenzijo posakonazola 800 mg/dan v deljenih odmerkih.
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C04.
Slovenian: Oznaka ATC: J02A C04.
English: Liquid glucose
Slovenian: Alkaloidi vinke
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Noxafil.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete jemati zdravilo Noxafil.
English: - The active substance in Noxafil is posaconazole.
Slovenian: - Učinkovina v zdravilu Noxafil je posakonazol.
English: Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial.
Slovenian: V neprimerjalnem preskušanju zadnje možnosti zdravljenja so za zdravljenje invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B (vključno z liposomskimi oblikami) ali itrakonazol, oziroma pri bolnikih, ki niso prenašali teh zdravil, ovrednotili peroralno suspenzijo posakonazola 800 mg/dan v deljenih odmerkih.
English: • nausea or vomit (feeling or being sick), diarrhoea
Slovenian: • slabost v želodcu (siljenje na bruhanje) ali bruhanje, driska
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Noxafil.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom, preden začnete jemati zdravilo Noxafil.
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, infusion site pain, infusion site phlebitis, infusion site thrombosis, mucosal inflammation
Slovenian: edemi, bolečine, mrzlica, splošno slabo počutje, nelagodje v prsnem košu, neprenašanje zdravila, občutek živčnosti, bolečine na mestu infundiranja, flebitis na mestu infundiranja, tromboza na mestu infundiranja, vnetje sluznice
English: What Noxafil contains The active substance is posaconazole.
Slovenian: Zdravilo Noxafil vsebuje učinkovino posakonazol.
English: Proportion (%) of patients with proven/probable IFIs On-treatment period
Slovenian: Odstotek (%) bolnikov z dokazanimi oziroma verjetnimi invazivnimi glivnimi okužbami Obdobje zdravljenja
English: Amikacin sulfate
Slovenian: PRETISNI OMOTI
English: There is no paediatric experience with posaconazole tablets.
Slovenian: Izkušenj s tabletami posakonazola pri pediatričnih bolnikih ni.
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Slovenian: edemi, bolečine, mrzlica, splošno slabo počutje, nelagodje v prsnem košu, neprenašanje zdravila, občutek živčnosti, vnetje sluznice
English: Control
Slovenian: Kontrolna skupina
English: Ear and labyrinth disorder Rare:
Slovenian: Motnje reprodukcije in dojk Občasni:
English: After administration of
Slovenian: Po uporabi