natgillin/translations-raw huggingface dataset:
Breast-feeding must be stopped on initiation of treatment with posaconazole.
Ob uvedbi zdravljenja s posakonazolom je treba prenehati z dojenjem.
• mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain
• blaga do huda slabost v želodcu, bruhanje, krči in driska (po navadi so vzrok virusi), bolečine v trebuhu
hypertension hypotension, vasculitis
hipertenzija hipotenzija, vaskulitis
• oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain
• prekinitev preskrbe vranice s kisikom (vranični infarkt) - povzroči lahko hude bolečine v trebuhu
Noxafil may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Zdravilo Noxafil morda lahko poveča tveganje za pojav neželenih učinkov nekaterih drugih zdravil, ker poveča njihovo količino v krvi.
• bleeding into your stomach or gut - signs include vomiting blood or passing blood in your stool
• krvavitev v želodec ali črevo - med znaki so bruhanje krvi ali kri v blatu
As a result, sirolimus trough concentrations that fall within the usual therapeutic range may result in sub-therapeutic levels.
Zaradi tega lahko najnižja koncentracija sirolimusa, ki je še v običajnem terapevtskem razponu, dejansko pomeni koncentracijo, nižjo od terapevtske.
Uncommon: the following may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri največ 1 od 100 oseb
Prophylaxis of invasive fungal infections
Profilaksa invazivnih glivnih okužb
Noxafil contains approximately 1.75 g of glucose per 5 mL of suspension.
Zdravilo Noxafil vsebuje približno 1,75 g glukoze na 5 ml suspenzije.
• are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).
• če jemljete vinkristin, vinblastin ali druge "alkaloide vinke" (zdravila za zdravljenje raka).
During post-marketing surveillance severe hepatic injury with fatal outcome has been reported (see section 4.4).
Med spremljanjem v obdobju trženja so poročali o hudi okvari jeter s smrtnim izidom (glejte poglavje 4.4).
In patients, mean maximum plasma concentrations (Cmax) after posaconazole concentrate for solution for infusion are 4-fold increased compared to administration of oral suspension.
Pri bolnikih je bila povprečna največja koncentracija v plazmi (Cmax) po uporabi posakonazola v koncentratu za raztopino za infundiranje 4-krat večja kot po uporabi peroralne suspenzije.
Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), and efavirenz
Rifamicinski antibiotiki (rifampicin, rifabutin), določeni antikonvulzivi (fenitoin, karbamazepin, fenobarbital, primidon) in efavirenz
• abnormal heart rhythm - shown up on a heart trace (ECG), palpitations, slow or fast heartbeat,
• motnje srčnega ritma - pokažejo se na zapisu električnega delovanja srca (EKG), razbijanje srca (palpitacije), počasno ali hitro bitje srca, visok ali nizek krvni tlak
Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
Sočasna uporaba azolskih antimikotikov, vključno s posakonazolom, in vinkristina je bila povezana z resnimi neželenimi učinki (glejte poglavje 4.4).
Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Sočasni uporabi posakonazola in fenitoina ter podobnih induktorjev (npr. karbamazepina, fenobarbitala, primidona) se je treba izogibati, razen če korist za bolnika odtehta tveganje.
Certain medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in the blood.
Določena zdravila lahko povečajo tveganje za pojav neželenih učinkov zdravila Noxafil, ker povečajo količino zdravila Noxafil v krvi.
Treatment of refractory Fungal Infections (Invasive aspergillosis, Fusariosis,
Zdravljenje rezistentnih glivnih okužb (invazivna aspergiloza, fusarioza, kromoblastomikoza/micetom, kokcidioidomikoza)
• infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped;
• okužb, ki jih povzročajo glive iz družine Fusarium in ki se niso izboljšale med zdravljenjem z amfotericinom B, ali če je bilo treba amfotericin B ukiniti;
What you need to know before you take Noxafil
Kaj morate vedeti, preden boste vzeli zdravilo Noxafil
convulsions, neuropathy, hypoaesthesia, tremor, aphasia, insomnia
konvulzije, nevropatija, hipestezija, tremor, afazija, nespečnost
pulmonary embolism, deep vein thrombosis
pljučna embolija, globoka venska tromboza
Due to the risk of prolonged sedation and possible respiratory depression co-administration of posaconazole with any benzodiazepines metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam) should only be considered if clearly necessary.
Zaradi tveganja pojava dolgotrajne sedacije in morebitne depresije dihanja lahko sočasna uporaba posakonazola in katerega koli benzodiazepina, ki se presnavlja s CYP3A4 (npr. midazolam, triazolam, alprazolam) pride v poštev le, če je brez dvoma potrebna.
Both doses of posaconazole increased Cmax and AUC of oral midazolam (2 mg single oral dose) by 2.2 and 4.5-fold, respectively.
Oba odmerka posakonazola sta povečala Cmax peroralno uporabljenega midazolama (enkratni peroralni odmerek 2 mg) za 2,2-krat in njegovo AUC za 4,5-krat.
Eleven patients received a single dose of 200 mg posaconazole concentrate for solution for infusion, 21 patients received 200 mg daily dose for a median of 14 days, and 237 patients received 300 mg daily dose for a median of 9 days.
Enajst bolnikov je dobilo enkraten odmerek 200 mg posakonazola v koncentratu za raztopino za infundiranje, 21 bolnikov je dobivalo dnevni odmerek 200 mg mediano 14 dni,
• high blood levels of creatinine - shown in blood tests
• visoka koncentracija kreatinina v krvi - pokaže se na preiskavah krvi
There were fewer breakthrough Aspergillus infections in patients receiving posaconazole prophylaxis when compared to control patients.
Med bolniki, ki so prejemali profilakso s posakonazolom, je bilo prebijajočih okužb z Aspergillusom manj kot med primerjalnimi bolniki.
The other ingredients are: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid (concentrated), sodium hydroxide, water for injections.
Druge sestavine zdravila so: natrijev sulfobutileter betaciklodekstrin (SBECD), dinatrijev edetat, klorovodikova kislina (koncentrirana), natrijev hidroksid, voda za injekcije.
Method of administration For oral use
Način uporabe za peroralno uporabo
• vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
• vinkristin, vinblastin in drugi alkaloidi vinke (uporabljajo se za zdravljenje raka),
Noxafil concentrate for solution for infusion was investigated in AML and MDS patients and those after HSCT with or at risk for GVHD only.
Zdravilo Noxafil koncentrat za raztopino za infundiranje so raziskali pri bolnikih z AML ali MDS in pri bolnikih s HSCT, vendar le pri tistih, ki so imeli bolezen presadka proti gostitelju (GVHD) ali tveganje zanjo.
In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with Noxafil.
Poleg zgoraj navedenih zdravil so s tveganjem za motnje srčnega ritma povezana še druga zdravila in tveganje je lahko večje, če takšna zdravila jemljete skupaj z zdravilom Noxafil.
• blood clots in your legs (deep vein thrombosis) - signs include intense pain or swelling of the legs
• krvni strdki v nogah (globoka venska tromboza) - med znaki so močne bolečine ali oteklost nog
Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.
Teste delovanja jeter je treba opraviti na začetku zdravljenja s posakonazolom in med zdravljenjem z njim.
Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45 % and 50 %, respectively.
Efavirenz (400 mg enkrat na dan) je zmanjšal Cmax posakonazola za 45 %, njegovo AUC pa za 50 %.
Posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Posakonazol je povečal Cmax rifabutina za 31 % in AUC rifabutina za 72 %.
Noxafil should be administered via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes.
Zdravilo Noxafil je treba dajati po centralni venski liniji, ki vključuje centralni venski kateter ali periferno vstavljen centralni kateter (PICC), v počasni intravenski infuziji približno 90 minut.
What Noxafil is and what it is used for What you need to know before you take Noxafil How to take Noxafil
Kaj je zdravilo Noxafil in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Noxafil Kako jemati zdravilo Noxafil Možni neželeni učinki
It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens and the effects of food on absorption).
okuženih z Aspergillusom (glejte poglavji 4.2 in 5.2 o priporočenih režimih odmerjanja in učinkih hrane na absorpcijo).
In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with posaconazole.
Poleg zgoraj navedenih zdravil so s tveganjem za motnje srčnega ritma povezana še druga zdravila in tveganje je lahko večje, če takšna zdravila jemljete skupaj s posakonazolom.
The blockage will prevent the contents of your intestine from passing through to the lower bowel signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
Takšna zapora prepreči prehajanje črevesne vsebine v spodnji del črevesa; med znaki so občutek napihnjenosti, bruhanje, hudo zaprtje, izguba apetita in krči
• anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests
• anemija - med znaki so glavoboli, utrujenost ali omotičnost, kratka sapa ali bledica ter nizka koncentracija hemoglobina, ki se pokaže na preiskavah krvi
• Do not use this medicine after the expiry date which is stated on the blister after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Hypromellose acetate succinate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Silica dental type Croscarmellose sodium Magnesium stearate
Jedro tablete hipromeloza acetat sukcinat mikrokristalna celuloza hidroksipropilceluloza (E463) silicijev dioksid dentalnega tipa premreženi natrijev karmelozat magnezijev stearat
What Noxafil is and what it is used for What you need to know before you use Noxafil How to use Noxafil
Kaj je zdravilo Noxafil in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Noxafil Kako uporabljati zdravilo Noxafil Možni neželeni učinki
Noxafil works by killing or stopping the growth of some types of fungi that can cause infections.
Zdravilo Noxafil deluje tako, da uniči nekatere vrste gliv, ki lahko povzročajo okužbe, ali ustavi njihovo rast.
Cases of elevated ciclosporin levels resulting in serious adverse reactions, including nephrotoxicity and one fatal case of leukoencephalopathy, were reported in clinical efficacy studies.
V študijah klinične učinkovitosti so poročali o primerih povečane koncentracije ciklosporina, ki je povzročila resne neželene učinke, vključno z nefrotoksičnostjo in enim smrtnim primerom levkoencefalopatije.
• infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;
• okužb z glivami, ki povzročajo bolezni, imenovani "kromoblastomikoza" in "micetom", ki se niso izboljšale med zdravljenjem z itrakonazolom ali če je bilo treba zdravljenje z itrakonazolom ukiniti;
• swelling of the mouth
• otekanje v ustih
Co-administration of posaconazole with proton pump inhibitors should be avoided if possible.
Sočasni uporabi posakonazola in zaviralcev protonske črpalke se je treba izogibati, če je le mogoče.
Each dose of Noxafil should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.
Bolniki, ki ne prenašajo hrane, naj zdravilo vzamejo med ali takoj po zaužitju prehranskega dodatka, da bi povečali peroralno absorpcijo in zagotovili zadostno izpostavljenost zdravilu.
Two different dosing groups were evaluated in Cohorts 1 and 2: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Cohort 1) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Cohort 2).
V kohortah 1 in 2 so ocenili skupini z dvema različnima odmerjanjema: 200 mg dvakrat na dan 1. dan in nato 200 mg enkrat na dan (kohorta 1) ter 300 mg dvakrat na dan 1. dan in nato 300 mg enkrat na dan (kohorta 2).
Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (1.7 times the 400-mg twice daily regimen based on steady-state plasma concentrations in healthy volunteers) or female rats at a dose up to 45 mg/kg (2.2 times the 400-mg twice daily regimen).
Posakonazol ni vplival na plodnost podganjih samcev v odmerkih do 180 mg/kg (1,7-krat 400 mg režim dvakrat na dan, ki temelji na plazemskih koncentracijah v stanju dinamičnega ravnovesja pri zdravih prostovoljcih) ali podganjih samic v odmerku do 45 mg/kg (2,2-krat 400 mg režim dvakrat na dan).
After oral administration, posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Po peroralni uporabi je posakonazol povečal Cmax rifabutina za 31 % in AUC rifabutina za 72 %.
11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
11 od 16 bolnikov so uspešno zdravili (ob koncu zdravljenja popolno ali delno izginotje izhodiščnih znakov in simptomov) s peroralno suspenzijo posakonazola 800 mg/dan v deljenih odmerkih.
H2 receptor antagonists and proton pump inhibitors No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Antagonisti receptorjev H2 in zaviralci protonske črpalke Med sočasno uporabo tablet posakonazola in antacidov, antagonistov receptorjev H2 in zaviralcev protonske črpalke niso opazili klinično pomembnih učinkov.
It should be noted that the relationship between sirolimus trough concentration and AUC is changed during coadministration with posaconazole.
Zavedati se je treba, da se med sočasno uporabo sirolimusa in posakonazola spremeni razmerje med najnižjo koncentracijo sirolimusa in njegovo AUC.
Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
V 2-letni študiji na podganah so opažali pljučno fosfolipidozo, ki je povzročila dilatacijo in obstrukcijo alveolov.
If you think that you may have taken too much Noxafil, talk to a doctor or go to the hospital straight away.
Če ste vzeli večji odmerek zdravila Noxafil, kot bi smeli Če menite, da ste vzeli preveč zdravila Noxafil, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico.
Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukaemia or myelodysplastic syndromes.
Študija 1899 je bila randomizirana, za ocenjevalce slepa študija, ki je primerjala uporabo peroralne suspenzije posakonazola (200 mg trikrat na dan) in suspenzije flukonazola (400 mg enkrat na dan) ali peroralne raztopine itrakonazola (200 mg dvakrat na dan) pri bolnikih z nevtropenijo, ki so prejemali citotoksično kemoterapijo zaradi akutne mieloične levkemije ali mielodisplastičnih sindromov.
c: In 1899, this was the period from randomisation to 100 days post-randomisation; in 316 it was the period from the baseline day to 111 days post-baseline.
c: V študiji 1899 je bilo to obdobje od randomizacije do 100. dne po randomizaciji, v študiji 316 pa od začetka študije do
What Noxafil looks like and contents of the pack Noxafil concentrate for solution for infusion is a clear, colourless to yellow liquid.
Zdravilo Noxafil koncentrat za raztopino za infundiranje je bistra, brezbarvna do rumena tekočina.
Caution is advised during coadministration of posaconazole with CYP3A4 substrates administered intravenously and the dose of the CYP3A4 substrate may need to be reduced.
Med sočasno uporabo posakonazola in intravensko danih substratov CYP3A4 je potrebna previdnost in po potrebi zmanjšanje odmerka substrata CYP3A4.
If you are a woman who could become pregnant you should use effective contraception while you are using Noxafil.
Če ste ženska v rodni dobi, morate med uporabo zdravila Noxafil uporabljati učinkovito kontracepcijo.
haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
hemolitično-uremični sindrom, trombotična trombocitopenična purpura, pancitopenija, koagulopatija, krvavitev
Clinically significant interactions resulting in hospitalisation and/or posaconazole discontinuation were reported in clinical efficacy studies.
V študijah klinične učinkovitosti so poročali o klinično pomembnih interakcijah, ki so zahtevale sprejem v bolnišnico in/ali ukinitev posakonazola.
In a study (Study 03579) of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL) (see section 5.2).
V študiji (študija 03579) pri 136 nevtropeničnih pediatričnih bolnikih, starih od 11 mesecev do 17 let, zdravljenih s peroralno suspenzijo posakonazola v odmerkih do 18 mg/kg/dan, razdeljenih na tri odmerke dnevno, je približno 50 % bolnikov doseglo vnaprej določen cilj (povprečna koncentracija v stanju dinamičnega ravnovesja (Cav) 7. dan med 500 ng/ml in 2.500 ng/ml) (glejte poglavje 5.2).
In a study of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL).
V študiji pri 136 nevtropeničnih pediatričnih bolnikih, starih od 11 mesecev do 17 let, zdravljenih s peroralno suspenzijo posakonazola v odmerkih do 18 mg/kg/dan, razdeljenih na tri odmerke dnevno, je približno 50 % bolnikov doseglo vnaprej določen cilj (Cav 7. dan med 500 ng/ml in 2.500 ng/ml).
Similarly, administration of 400 mg posaconazole with esomeprazole (40 mg daily) decreased mean Cmax and AUC by 46 % and 32 %, respectively, compared to dosing with 400 mg posaconazole alone.
Podobno sta se pri jemanju 400 mg posakonazola z esomeprazolom (40 mg na dan) v primerjavi z jemanjem samega posakonazola v odmerku 400 mg zmanjšali srednja vrednost Cmax oz. srednja vrednost AUC za 46 % oz. 32 %.
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC04.
Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, derivati triazola.
• breast pain
• bolečine v dojkah
The subject population in Cohort 3 included: 1) patients with AML or MDS who had recently received chemotherapy and had developed or were anticipated to develop significant neutropenia, or 2) patients who had undergone a HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD.
Populacija preiskovancev v kohorti 3 je vključevala: 1) bolnike z AML ali MDS, ki so nedavno prejemali kemoterapijo in se jim je pojavila, ali je bilo pričakovano, da se jim bo pojavila pomembna nevtropenija, oziroma 2) bolnike, ki so imeli opravljeno presaditev hematopoetskih matičnih celic (HSCT) in so prejemali imunosupresivno zdravljenje za preprečevanje ali zdravljenje GVHD.
Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/mL) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/mL).
Po uporabi 800 mg posakonazola na dan v deljenih odmerkih za zdravljenje invazivnih glivnih okužb je bila povprečna najmanjša plazemska koncentracija pri 12 bolnikih, starih od 8 do 17 let (776 ng/ml), podobna kot pri 194 bolnikih, starih od 18 do 64 let (817 ng/ml).
• low level of platelets (thrombocytopenia) shown in blood tests - this may lead to bleeding
• nizko število trombocitov (trombocitopenija), ki se pokaže na preiskavah krvi - povzroči lahko krvavitve
Two different dosing groups were evaluated: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Part IA) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Part 1B and Part 2).
Ocenili so skupini z dvema različnima odmerjanjema: 200 mg dvakrat na dan 1. dan in nato 200 mg enkrat na dan (del IA) in 300 mg dvakrat na dan 1. dan in nato 300 mg enkrat na dan (del IB in del 2).
Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41 % and 50 %, respectively.
Fenitoin (200 mg enkrat na dan) je zmanjšal Cmax posakonazola za 41 %, njegovo AUC pa za 50 %.
• stuffy nose
• zamašen nos
Noxafil oral suspension and tablets are NOT interchangeable.
Noxafil peroralna suspenzija NI medsebojno zamenljiva z Noxafil tabletami.
• low magnesium levels - shown up in blood tests
• nizka koncentracija magnezija - pokaže se na preiskavah krvi
torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
torsades de pointes, nenadna smrt, ventrikularna tahikardija, zastoj srca in dihanja, srčno popuščanje, miokardni infarkt
• low levels of “neutrophils” a type of white blood cell (neutropenia) - this can make you more likely to get infections and be shown up in blood tests
• nizko število nevtrofilcev - vrste belih krvnih celic (nevtropenija) - ki lahko poveča tveganje za okužbe in se pokaže na preiskavah krvi
BOTTLE LABEL
NALEPKA NA STEKLENIČKI
Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections (Study 0041).
Šestnajst bolnikov, starih od 8 do 17 let, so v študiji invazivnih glivnih okužb zdravili s peroralno suspenzijo posakonazola v odmerku 800 mg/dan (študija 0041).
Do not use Noxafil if any of the above apply to you.
Ne uporabljajte zdravila Noxafil, če kaj od naštetega velja za vas.
Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (2.8 times the exposure achieved from a 300 mg intravenous dose in human) or female rats at a dose up to 45 mg/kg (3.4 times the exposure from a 300 mg intravenous dose in patients).
Posakonazol ni vplival na plodnost podganjih samcev v odmerkih do 180 mg/kg (2,8-krat tolikšna izpostavljenost, kot je dosežena z intravenskim odmerkom 300 mg pri človeku) ali podganjih samic v odmerku do 45 mg/kg (3,4-krat tolikšna izpostavljenost kot z intravenskim odmerkom 300 mg pri bolnikih).
Clinical success rates in Oropharyngeal Candidiasis Endpoint
Klinična uspešnost pri orofaringealni kandidozi Opazovani dogodek
The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Med najpogosteje poročanimi resnimi, z zdravilom povezanimi neželenimi učinki so bili navzea, bruhanje, driska, zvišana telesna temperatura in zvišana raven bilirubina.
• swelling of lymph glands (lymphadenopathy)
• oteklost bezgavk (limfadenopatija)