natgillin/translations-raw huggingface dataset:
Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazole Cmax ↔ Voriconazole AUCτ ↔
indinavir Cmax ↔ indinavir AUCτ ↔ vorikonazol Cmax ↔ vorikonazol AUCτ ↔
Pharmacotherapeutic group: Antimycotics for systemic use, - triazole derivatives ATC code: J02AC03
Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, derivati triazola oznaka ATC: J02AC03
It is recommended that all patients, including children, avoid exposure to direct sunlight during VORICONAZOLE HIKMA treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Priporočljivo je, da se vsi bolniki, vključno z otroci, med zdravljenjem z zdravilom VORIKONAZOL HIKMA izogibajo izpostavljenosti neposredni sončni svetlobi in sledijo ukrepom, kot so zaščitna oblačila in krema za zaščito pred soncem z visokim zaščitnim faktorjem.
Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
ciklosporin (pri stabilnih prejemnikih presajene ledvice, ki prejemajo kronično terapijo s ciklosporinom)
Patients must avoid potentially hazardous tasks, such as driving or operating machinery while experiencing these symptoms.
Bolniki se morajo med doživljanjem teh simptomov izogibati opravljanju potencialno nevarnih opravil kot na primer vožnja ali upravljanje s stroji.
The breakthrough IFI rate to Day 180 and the primary endpoint of the study, which is Success at Day 180, for patients with AML and myeloablative conditioning regimens respectively, is presented in the table below:
Delež izbruha IGO do 180. dneva in primarni opazovani dogodek v študiji, ki je uspešnost na 180. dan, sta za bolnike z AML in mieloablativnim režimom prikazana v spodnjih preglednicah:
Carcinogenicity studies were not performed with SBECD.
Študij karcinogenosti SBECD ni bilo.
Serious refractory Candida infections
Hude refraktarne okužbe s Candido
A positive association between mean, maximum or minimum plasma voriconazole concentration and efficacy in therapeutic studies was not found and this relationship has not been explored in prophylaxis studies.
Pozitivne povezave med povprečno, največjo ali najmanjšo koncentracijo vorikonazola v plazmi ter učinkovitostjo v terapevtskih študijah niso ugotovili, v študijah profilakse pa te povezave niso raziskovali.
The safety and efficacy of voriconazole in children below 2 years has not been established.
Varnost in učinkovitost vorikonazola pri otrocih, mlajših od 2 let, nista bili dokazani.
2 Includes immune thrombocytopenic purpura.
2 Vključuje imunsko trombocitopenično purpuro.
5 Includes akathisia and parkinsonism.
5 Vključuje akatizije in parkinsonizem.
Not recommended
Ni priporočljivo.
The MITT group included 40 patients with prior IFI, including 31 with aspergillosis, 5 with candidiasis, and 4 with other IFI.
V skupini MITT je bilo 40 bolnikov s predhodno IGO, vključno z 31 bolniki z aspergilozo, 5 bolniki s kandidozo in 4 bolniki z drugimi IGO.
If any of these side effects persist or are troublesome, please tell your doctor.
Če je katerikoli od teh neželenih učinkov trdovraten ali moteč, povejte zdravniku.
Compatible Infusion Solutions: The reconstituted solution can be diluted with:
Združljive raztopine za infundiranje: Pripravljeno (rekonstituirano) raztopino je mogoče redčiti z:
The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
Varnostni profil vorikonazola je bil pri mladih in starejših bolnikih podoben, zato pri starejših odmerka ni treba prilagajati (glejte poglavje 4.2).
It is estimated that, on average, increasing the oral dose from 200 mg twice daily to 300 mg twice daily leads to a 2.5-fold increase in exposure (AUCτ).
Ocenjujejo, da povečanje peroralnega odmerka z 200 mg dvakrat na dan na 300 mg dvakrat na dan povzroči v povprečju 2,5-kratno povečanje izpostavljenosti (AUCτ).
The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Spremenjena skupina bolnikov, ki so jih nameravali zdraviti (modified intent-to-treat - MITT), je vključevala 465 prejemnikov homolognih HSCT, od katerih jih je 45 % imelo akutno mieloično levkemijo (AML).
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani evropske Agencije za zdravila http://www.ema.europa.eu.
All occurred in paediatric patients, who received up to five times the recommended intravenous dose of voriconazole.
Do vseh je prišlo pri pediatričnih bolnikih, ki so dobili do petkratni priporočeni intravenski odmerek vorikonazola.
• candidaemia (another type of fungal infection due to Candida sp.) in non-neutropenic patients (patients without abnormally low white blood cell count),
• s kandidemijo (druga vrsta glivične okužbe, ki jo povzročajo vrste Candida) pri nenevtropeničnih bolnikih (bolniki, ki nimajo nenormalno zmanjšanega števila belih krvnih celic),
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to <18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Varnost vorikonazola so raziskali pri 288 pediatričnih bolnikih, starih od 2 do < 12 let (169) in od 12 do < 18 let (119),, ki so vorikonazol v kliničnih preskušanjih dobivali za profilakso (183) in terapijo (105).
Oral dosage forms of voriconazole are available from other manufacturers.
Peroralne oblike vorikonazola so na voljo s strani drugih proizvajalcev.
3 Includes nuchal rigidity and tetany.
3 Vključuje rigidnost tilnika in tetanijo.
If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Če se vam pojavijo zgoraj opisane težave s kožo, vas bo vaš zdravnik morda napotil k dermatologu, ki se po posvetu lahko odloči, da je za vas pomembno, da ga redno obiskujete.
The study comprised 55 patients with serious refractory systemic Candida infections (including candidaemia, disseminated and other invasive candidiasis) where prior antifungal treatment, particularly with fluconazole, had been ineffective.
Študija je zajela 55 bolnikov s hudimi refraktarnimi sistemskimi okužbami s Candido (vključno s kandidemijo, diseminirano kandidiazo in drugimi invazivnimi oblikami kandidiaze), pri katerih prejšnje antimikotično zdravljenje, zlasti s flukonazolom, ni bilo učinkovito.
MIC breakpoint (mg/L)
Majna vrednost MIK (mg/L)
Voriconazole Hikma must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines.
Zdravila Vorikonazol Hikma se ne sme dajati sočasno s katerimkoli krvnim pripravkom ali s katerokoli kratkotrajno infuzijo koncentriranih raztopin elektrolitov, tudi če infuziji potekata po dveh ločenih linijah.
Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UK
Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW Velika Britanija
A satisfactory global response (complete or partial resolution of all attributable symptoms signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53 % of voriconazole-treated patients compared to 31 % of patients treated with comparator.
Zadovoljiv globalni odziv (popolno ali delno izginotje vseh izhodiščno prisotnih pripisljivih simptomov, znakov, rentgenoloških/bronhoskopskih nenormalnosti) so ugotovili pri 53 % bolnikov, zdravljenih z vorikonazolom, in pri 31 % bolnikov, zdravljenih s primerjalnim zdravilom.
Chemical and physical stability of the of the diluted solutions for infusion has been demonstrated for 36 hours at 2°C to 8°C followed by 3 hours at room temperature.
Kemična in fizikalna stabilnost razredčene raztopine za infundiranje med uporabo sta bili dokazani za 36 ur pri temperaturi med 2 °C in 8 °C, čemur so sledile 3 ure pri sobni temperaturi.
Extended and frequent monitoring for respiratory depression and other opiateassociated adverse reactions is recommended.
Priporočljiv je povečan in pogost nadzor glede pojavljanja depresije dihanja in drugih z opiati povezanih neželenih učinkov.
It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.
Zelo pomembno je, da obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, ali zdravilo rastlinskega izvora.
Dose reduction of methadone may be needed (see section 4.5).
Morda bo treba zmanjšati odmerek metadona (glejte poglavje 4.5).
AUCτ, AUCt and AUC0-∞ represent area under the curve over a dosing interval, from time zero to the time with detectable measurement and from time zero to infinity, respectively.
AUCτ, AUCt in AUC0-∞ predstavljajo površino pod krivuljo preko odmernega intervala, površino pod krivuljo od časa nič do časa detekcije in površino pod krivuljo od časa nič do neskončnosti.
• Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
• zdravljenje hudih, invazivnih, proti flukonazolu odpornih okužb s Candido (vključno s C. krusei)
Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation (HSCT)), should be monitored closely during voriconazole treatment.
Bolnike, še posebej otroke, z dejavniki tveganja za akutni pankreatitis (npr. nedavna kemoterapija, presaditev matičnih krvotvornih celic [HSCT - Haematopoietic Stem Cell Transplantation]) je treba med zdravljenjem z vorikonazolom skrbno nadzorovati.
In clinical trials there were 3 cases of accidental overdose.
V kliničnih preskušanjih so zabeležili 3 primere nenamernega prevelikega odmerjanja.
Patients receiving voriconazole must be carefully monitored for hepatic toxicity.
Bolnike, ki dobivajo vorikonazol, je treba skrbno nadzorovati glede hepatotoksičnosti.
The terminal half-life of voriconazole depends on dose and is approximately 6 hours at 200 mg (orally).
Končni razpolovni čas vorikonazola je odvisen od odmerka in znaša pri 200 mg (peroralno) približno 6 ur.
Use in paediatric patients aged 2 to <12 years with hepatic or renal insufficiency has not been studied (see sections 4.8 and 5.2).
Uporaba pri pediatričnih bolnikih, starih od 2 do < 12 let, z insuficienco jeter ali ledvic ni raziskana (glejte poglavji 4.8 in 5.2).
In the therapeutic studies no dosage adjustment was made on the basis of age.
V terapevtskih študijah odmerjanja niso prilagajali glede na starost.
The severity of the adverse reactions was generally mild to moderate.
Resnost neželenih učinkov je bila na splošno blaga do zmerna.
The volume of distribution at steady state for voriconazole is estimated to be 4.6 L/kg, suggesting extensive distribution into tissues.
Ocenjeni volumen porazdelitve vorikonazola v stanju dinamičnega ravnovesja je 4,6 l/kg, kar nakazuje na znatno porazdelitev v tkiva.
Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Prilagajanje odmerka (otroci [2 do < 12 let] in mlajši mladostniki z majhno telesno maso [12 do 14 let in < 50 kg])
For Caucasians and Blacks the prevalence of poor metabolisers is 3-5 %.
Med belci in črnci je prevalenca oseb z zmanjšano presnovo 3- 5 %.
Aspergillus infections - efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Okužbe z Aspergillusom - učinkovitost pri bolnikih z aspergilozo s slabo prognozo Vorikonazol deluje in vitro fungicidno proti Aspergillus spp.
In fluconazole-resistant non albicans species, a successful outcome was seen in 3/3 C. krusei (complete responses) and 6/8 C. glabrata (5 complete, 1 partial response) infections.
Pri ne-albicans vrstah, odpornih na flukonazol, so uspešen odziv ugotovili pri 3/3 okužbah s C. krusei (popolni odzivi) in 6/8 okužbah s C. glabrata (5 popolnih, 1 delni odziv).
A relationship between plasma concentrations and age was observed.
Opažali so razmerje med koncentracijo v plazmi in starostjo.
Body Weight (kg)
telesna masa (kg)
Stability after reconstitution:
Stabilnost po rekonstituciji:
Monitoring of pancreatic function
Nadzor delovanja pankreasa
You should avoid any sunlight and sun exposure while being treated.
Med zdravljenjem se povsem izogibajte sončni svetlobi in izpostavljenosti soncu.
The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C. tropicalis, C. glabrata and C. krusei, all of which usually exhibit minimum inhibitory concentration (MICs) of less than 1 mg/L for voriconazole.
Vrste, ki so najpogosteje vpletene pri povzročanju okužb pri ljudeh, so C. albicans, C. parapsilosis, C. tropicalis, C. glabrata in C. krusei, pri čemer pri vseh naštetih minimalna inhibitorna koncentracija (MIK) za vorikonazol običajno znaša manj kot 1 mg/L.
The recommended dosing regimen is as follows:
Priporočena shema odmerjanja je:
Safety and effectiveness in paediatric subjects below the age of two years has not been established (see sections 4.8 and 5.1).
Varnost in učinkovitost pri otrocih, mlajših od dveh let, ni raziskana (glejte poglavji 4.8 in 5.1).
If VORICONAZOLE HIKMA is continued, however, dermatologic evaluation should be performed on a systematic and regular basis, to allow early detection and management of premalignant lesions.
Če pa se zdravljenje z zdravilom VORIKONAZOL HIKMA nadaljuje, je treba bolnike redno in sistematično dermatološko ocenjevati, da se omogoči zgodnje odkrivanje in obravnavanje predrakavih lezij.
Infusion of total parenteral nutrition can occur silmultaneously with Voriconazole Hikma but not in the same line or cannula.
Sočasna infuzija popolne parenteralne prehrane z zdravilom Vorikonazol Hikma je možna, vendar ne v isto linijo ali kanilo.
This represents a heterogeneous population, containing patients with haematological malignancy, HIV infected patients with oesophageal candidiasis and refractory fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
Gre za heterogeno populacijo, ki zajema bolnike s hematološkimi malignomi, s HIV okužene bolnike s kandidiazo požiralnika in refraktarnimi glivičnimi okužbami, nenevtropenične bolnike s kandidemijo ali aspergilozo ter zdrave prostovoljce.
In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Pri 22 bolnikih, mlajših od dveh let, ki so dobivali vorikonazol v programu sočutne uporabe, so poročali o naslednjih neželenih učinkih (za katere povezava z vorikonzolom ni bila izključena): fotosenzitivnostna kožna reakcija (1), aritmija (1), pankreatitis (1), zvišanje ravni bilirubina v krvi (1), zvišanje ravni jetrnih encimov (1), izpuščaj (1) in edem papile vidnega živca (1).
• Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organs
• vnetje tankega tkiva, ki obdaja notranjo steno trebuha in prekriva organe v trebuhu
Voriconazole exposures in the majority of adolescent patients were comparable to those in adults receiving the same dosing regimens.
Izpostavljenosti vorikonazolu pri večini mladostnikov so bile primerljive tistim pri odraslih, ki so prejemali enake sheme odmerjanja.
In the same study, no significant differences in Cmax and AUCτ were observed between healthy elderly males and healthy elderly females (≥ 65 years).
V isti študiji niso ugotovili pomembnih razlik C maxin AUCτ med zdravimi starejšimi moški in zdravimi starejšimi ženskami (≥ 65 let).
Elevated liver enzymes were also observed more frequently in children.
Pri otrocih so pogosteje poročali tudi o zvišanih ravneh jetrnih encimov.
Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
Vorikonazola niso raziskovali pri bolnikih s hudo kronično cirozo jeter (Child-Pugh C).
Cimetidine (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH]
cimetidin (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH]
In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ml (inter-quartile range 1193 to 4380 ng/ml) and 3742 ng/ml (interquartile range 2027 to 6302 ng/ml), respectively.
V 10 terapevtskih študijah je bila mediana povprečne koncentracije v plazmi pri posameznih preskušancih v vseh študijah 2425 ng/ml (interkvartilni obseg od 1193 do 4380 ng/ml), mediana največje koncentracije v plazmi pa 3742 ng/ml (interkvartilni obseg od 2027 do 6302 ng/ml).
Because of non-linear pharmacokinetics, the terminal half-life is not useful in the prediction of the accumulation or elimination of voriconazole.
Zaradi nelinearne farmakokinetike končni razpolovni čas ne pomaga predvideti kopičenja ali izločanja vorikonazola.
Voriconazole Cmax and AUCτ ↔ The effect of voriconazole on either erythromycin or azithromycin is unknown.
vorikonazol Cmax in AUCτ ↔ Učinek vorikonazola na eritromicin ali azitromicin ni znan.
• You are suffering from, or have ever suffered from liver disease.
• imate ali ste v preteklosti imeli bolezen jeter.
Compared to efavirenz 600 mg QD,
v primerjavi s 600 mg efavirenza QD,
All other adolescents (12 to 14 years and ≥50 kg; 15 to 17 years regardless of body weight) Voriconazole should be dosed as adults.
Vsi drugi mladostniki (12 do 14 let in ≥ 50 kg; 15 do 17 let ne glede na telesno maso) Vorikonazol je treba odmerjati kot pri odraslih.
Dose reduction of methadone may be needed.
Morda bo treba odmerek metadona zmanjšati.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those that are obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
The absolute bioavailability of voriconazole after oral administration is estimated to be 96 %.
Ocenjena absolutna biološka uporabnost vorikonazola po peroralni uporabi je 96 %.
For patients with ICC the global response rate at EOT was 85.7% (6/7) and for patients with EC the global response rate at EOT was 70% (7/10).
Pri bolnikih z ICC je bila stopnja globalnega odziva ob koncu terapije 85,7 % (6/7), pri bolnikih z EC pa je bila stopnja globalnega odziva ob koncu terapije 70 % (7/10).
Primary Prophylaxis of Invasive Fungal Infections - Efficacy in HSCT recipients without prior proven or probable IFI
Primarna profilaksa invazivnih glivičnih okužb - učinkovitost pri prejemnikih HSCT brez predhodno dokazane ali verjetne IGO
This should be taken into consideration for patients on a controlled sodium diet.
To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
If you or your child are taking Voriconazole Hikma for prevention of fungal infections, your doctor may stop giving Voriconazole Hikma if you or your child develop treatment related side effects.
Če vi ali vaš otrok jemljete zdravilo Vorikonazol Hikma za preprečevanje glivičnih okužb, vam bo zdravnik morda prenehal dajati zdravilo Vrikonazol Hikma, če se pri vas ali vašem otroku pojavijo neželeni učinki, povezani z zdravljenjem
Serious side effects - Stop taking Voriconazole Hikma and see a doctor immediately
Resni neželeni učinki - prenehajte uporabljati zdravilo Vorikonazol Hikma in nemudoma poiščite zdravnika
• Low blood sugar, low blood potassium, low sodium in the blood
• nizka raven sladkorja v krvi, nizka raven kalija v krvi, nizka raven natrija v krvi
For patients with IA the overall rates of global response at 6 weeks were 64.3% (9/14), the global response rate was 40% (2/5) for patients 2 to <12 years and 77.8% (7/9) for patients 12 to <18 years of age.
Pri bolnikih z IA so bile celokupne stopnje globalnega odziva po 6 tednih 64,3 % (9/14), stopnja globalnega odziva za bolnike, stare od 2 do < 12 let, je bila 40 % (2/5), za bolnike, stare od 12 do < 18 let, pa 77,8 % (7/9).
Voriconazole Hikma must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g. Aminofusin 10% Plus).
Zdravila Vorikonazol Hikma se ne sme infundirati v isto linijo ali kanilo sočasno z infundiranjem drugih zdravil, vključno s parenteralno prehrano (npr. Aminofusin 10 % Plus).
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
In vitro je bilo dokazano delovanje proti naslednjim patogenom, vendar klinični pomen tega ni znan:
The intravenous vehicle, SBECD, is haemodialysed with a clearance of 55 ml/min.
Intravenski vehikel SBECD se hemodializira z očistkom 55 ml/min.
• serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).
• s hudimi glivičnimi okužbami, ki jih povzročajo vrste Scedosporium ali Fusarium (dve različni vrsti gliv).
• Cisapride (used for stomach problems)
• cisaprid (uporablja se proti težavam z želodcem)
The compatibility of Voriconazole Hikma with diluents other than listed above (or listed below under ‘Incompatibilities') is unknown.
Združljivost zdravila Vorikonazol Hikma z drugimi tekočinami razen zgoraj naštetih (ali omenjenih spodaj pod "Inkompatibilnosti") ni znana.
In the clinical programme, no dosage adjustment was made on the basis of gender.
V kliničnem programu odmerjanja niso prilagajali glede na spol.
Dermatological reactions were very common in patients treated with voriconazole in clinical trials, but these patients had serious underlying diseases and were receiving multiple concomitant medicinal products.
V kliničnih preskušanjih so bile dermatološke reakcije pri bolnikih, zdravljenih z vorikonazolom, zelo pogoste, toda ti bolniki so imeli hude že obstoječe bolezni in so sočasno dobivali več zdravil.
In addition VORICONAZOLE HIKMA has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Poleg tega je bilo zdravilo VORIKONAZOL HIKMA povezano s fototoksičnostjo, vključno z reakcijami, kot so efelide, lentigo, aktinična keratoza in psevdoporfirija.
4 EUCAST has not determined non-species related breakpoints for voriconazole.
4 EUCAST ni določil mejnih vrednosti za vorikonazol, ki niso povezane z vrsto.
Voriconazole is indicated for paediatric patients aged two years or older.
Vorikonazol je indiciran pri pediatričnih bolnikih, starih dve leti ali več.
• Everolimus (used for treating advanced kidney cancer and in transplant patients)
everolimus (uporablja se za zdravljenje napredovalega raka ledvic in pri bolnikih po presaditvi)
There is limited data on the safety of voriconazole in patients with abnormal liver function tests (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), or total bilirubin >5 times the upper limit of normal).
Na voljo so omejeni podatki o varnosti vorikonazola pri bolnikih z nenormalnimi testi jetrne funkcije (aspartat-aminotransferaza [AST], alanin-aminotransferaza [ALT], alkalna fosfataza [ALP] ali celotni bilirubin > 5-kratna zgornja meja normalne vrednosti).
Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended.
Priporočljiv je pogost nadzor neželenih učinkov in toksičnosti, povezanih z metadonom, vključno s podaljšanjem QTc.
The effects on parturition are probably mediated by species-specific mechanisms, involving reduction of oestradiol levels, and are consistent with those observed with other azole antifungal agents.
Učinki na porod se verjetno posredujejo z za živalsko vrsto specifičnimi mehanizmi, ki obsegajo zmanjšanje koncentracije estradiola in se skladajo z mehanizmi, ugotovljenimi pri drugih azolskih antimikotikih.