natgillin/translations-raw huggingface dataset:
However, tell your doctor or pharmacist if you think that a dose has been forgotten.
Vendar zdravniku ali farmacevtu vseeno povejte, če se vam zdi, da je bil odmerek pozabljen.
Prophylaxis should be initiated on the day of transplant and may be administered for up to 100 days.
Profilakso je treba začeti na dan transplantacije, uporablja pa se lahko največ 100 dni.
While affected, do not drive or operate any tools or machines.
Dokler občutite takšne učinke, ne smete voziti ali upravljati z orodji ali stroji.
This should include laboratory evaluation, particularly serum creatinine.
Nadzor mora vključevati laboratorijske preiskave, zlasti kreatinin v serumu.
• A disorder in which the body's immune system attacks part of the peripheral nervous system
• bolezen, pri kateri imunski sistem v telesu napade del perifernega živčevja
For example, 15-20 % of Asian populations may be expected to be poor metabolisers.
Tako je na primer mogoče pričakovati, da ima od 15 do 20 % azijske populacije zmanjšano presnovo.
This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100 % mortality).
Ta študija je potrdila izsledke zgodnejše, prospektivne študije, v kateri so ugotovili pozitiven izid pri preskušancih z dejavniki tveganja za slabo prognozo, vključno z boleznijo presadka proti gostitelju in, še posebej, možganskimi okužbami (ki so običajno povezane s skoraj 100 % umrljivostjo).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika, vendar čas običajno ne sme presegati 24 ur pri temperaturi med 2 °C in 8 °C (v hladilniku), razen če ni rekonstitucija opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory.
Preverjanja identifikacije in občutljivosti na protimikrobno zdravilo pri vsakem takem izolatu je treba ponoviti, če pa je rezultat potrjen, je treba izolat poslati v referenčni laboratorij.
Maximum increase in prothrombin time was approximately 2-fold
Največje podaljšanje protrombinskega časa je bilo približno 2-kratno.
The majority (> 94 %) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Večina (> 94 %) celotne radioaktivnosti se tako po peroralni kot po intravenski uporabi izloči v prvih 96 urah.
The recommended dosing regimen for prophylaxis is the same as for treatment in the respective age groups.
Priporočeni režim odmerjanja pri profilaksi je enak kot pri zdravljenju pri ustreznih starostnih skupinah.
Insufficient evidence
Ni dovolj dokazov
This enzyme exhibits genetic polymorphism.
Ta encim kaže genetski polimorfizem.
Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Bolniki z oslabelim imunskim sistemom ali s težkimi okužbami bodo morda za preprečitev ponovitve okužbe potrebovali dolgotrajno zdravljenje.
Dosage adjustment (Adults)
Prilagajanje odmerka (odrasli)
Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Od teh 7 bolnikov so 3 imeli okužbo oči, 1 okužbo sinusov in 3 diseminirano okužbo.
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Ker boste zdravilo dobivali pod natančnim zdravniškim nadzorom, je malo verjetno, da bi bil kakšen odmerek izpuščen.
• Treatment of invasive aspergillosis.
• zdravljenje invazivne aspergiloze
Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children.
Sončne opekline ali hude kožne reakcije po izpostavljanju svetlobi ali soncu so bile pogostejše pri otrocih.
Depending upon your response to treatment, your doctor may increase or decrease the daily dose.
Odvisno od vašega odziva na zdravljenje bo zdravnik morda povečal ali zmanjšal vaš dnevni odmerek..
Other significant side effects whose frequency is not known, but should be reported to your doctor immediately:
Drugi pomembni neželeni učinki z neznano pogostnostjo, pri katerih morate nemudoma obvestiti zdravnika:
Detailed information on dosage recommendations is provided in the following table:
Podrobne informacije o priporočilih za odmerjanje prikazuje naslednja preglednica:
Interaction Geometric mean changes (%)
Interakcija sprememba geometrične srednje vrednosti (%)
1 Includes febrile neutropenia and neutropenia.
1 Vključuje febrilno nevtropenijo in nevtropenijo.
Candida Species
Vrsta Candida
However, this reduced response was not correlated with elevated MICs.
Vendar pa ta zmanjšan odziv ni bil v korelaciji s povečanimi minimalnimi inhibitornimi koncentracijami (MIK).
Clinical studies examining QTc interval
Klinične študije, ki so preučevale interval QTc
Treatment should be as short as possible, however, if based on the benefit-risk assessment the treatment is continued (see section 4.2), monitoring frequency can be reduced to monthly if there are no changes in the liver function tests.
Trajanje zdravljenja mora biti čim krajše, če pa se na podlagi ocene koristi in tveganj zdravljenje nadaljuje (glejte poglavje 4.2), se lahko pogostost nadzora zmanjša na enkrat mesečno, če ni sprememb vrednosti testov jetrne funkcije.
The majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy.
Večina nenormalnih testov jetrne funkcije je izginila med zdravljenjem brez prilagoditve odmerka, ali pa po prilagoditvi odmerka, vključno s prekinitvijo zdravljenja.
• Abnormal sense of taste
• nenormalno zaznavanje okusa
• Sinus bradycardia
• sinusna bradikardija,
• Treatment of serious fungal infections caused by Scedosporium spp.
• zdravljenje hudih glivičnih okužb, ki jih povzročajo Scedosporium spp.
• Bleeding in the eye
• krvavitve v očesu
Post-marketing data suggest there might be a higher occurrence of skin reactions (especially erythema) in the paediatric population compared to adults.
Podatki iz obdobja trženja kažejo, da je možna večja pojavnost kožnih reakcij (zlasti eritem) pri pediatrični populaciji v primerjavi z odraslimi.
Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Običajne študije farmakološke varnosti, genotoksičnosti in karcinogenega potenciala niso kazale posebnega tveganja za človeka.
The interactions in the table are presented in the following order: contraindications, those requiring dose adjustment and careful clinical and/or biological monitoring, and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field.
Medsebojna delovanja v preglednici so predstavljena v sledečem vrstnem redu: kontraindikacije, delovanja, ki potrebujejo prilagajanje odmerka ter skrben klinični in/ali biološki nadzor, in nazadnje delovanja, ki nimajo pomembnih farmakokinetičnih interakcij, a bi lahko imela klinični pomen v tem terapevtskem področju.
In the light of these data the duration of treatment of the intravenous formulation should be no longer than 6 months.
V luči teh podatkov zdravljenje z intravenskim pripravkom ne sme trajati več kot 6 mesecev.
Blood products and short-term infusion of concentrated solutions of electrolytes:
Krvni pripravki in kratkotrajne infuzije koncentriranih raztopin elektrolitov:
: Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
: Sedem (3 popolni, 4 delni odzivi) od 17 bolnikov je bilo uspešno zdravljenih z vorikonazolom.
Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180 days after HSCT.
Uspešnost je bila opredeljena kot zmožnost nadaljevanja profilakse s preiskovanim zdravilom 100 dni po HSCT (brez prekinitve > 14 dni) in preživetje 180 dni po HSCT brez dokazane ali verjetne IGO.
Medicinal product [Mechanism of Interaction]
Zdravilo [mehanizem interakcije]
• Abnormal electrocardiogram (ECG)
• nenormalen elektrokardiogram (EKG)
Packs of 1 or 5 vials.
Pakiranja po 1 ali 5 vial.
Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”).
Interakcije med vorikonazolom in drugimi zdravili so navedene v spodnji preglednici (enkrat na dan kot “QD”, dvakrat na dan kot “BID”, trikrat na dan kot “TID” in ni določeno kot “ND”).
• Existing symptomatic arrhythmias
• obstoječe simptomatske aritmije,
8 See section 4.4.
8 Glejte poglavje 4.4.
6 See “Visual impairments” paragraph in section 4.8.
6 Glejte odstavek "Okvare vida" v poglavju 4.8.
The median treatment duration was 15 days in both treatment arms.
Mediano trajanje zdravljenja je bilo v obeh terapevtskih krakih 15 dni.
• Deterioration of brain function that is a serious complication of liver disease
• poslabšanje delovanja možganov, ki je resen zaplet bolezni jeter
No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Analiza varnostnih podatkov ni pokazala klinično pomembnih razlik glede na starost, raso ali spol.
One study enrolled 31 patients with possible, proven or probable invasive aspergillosis (IA), of whom 14 patients had proven or probable IA and were included in the MITT efficacy analyses.
V eno študijo so vključili 31 bolnikov z možno, potrjeno ali verjetno invazivno aspergilozo (IA), od katerih je 14 bolnikov imelo potrjeno ali verjetno IA in so jih vključili v analize učinkovitosti MITT.
Patients less than 40 kg**
bolniki s telesno maso manj kot 40 kg **
Prophylaxis in Adults and Children
Profilaksa pri odraslih in otrocih
The reduced dose and/or frequency of voriconazole and fluconazole that would eliminate this effect have not been established.
Zmanjšanega odmerka in/ali pogostnosti jemanja vorikonazola in flukonazola, ki bi preprečil pojav tega učinka, niso ugotovili.
The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Smer puščice za vsak farmakokinetični parameter temelji na 90 % intervalu zaupanja razmerja geometrične srednje vrednosti, ki je lahko znotraj (↔), pod (↓) ali nad (↑) območjem 80-125 %.
This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole.
Ta presnovek deluje minimalno antimikotično in ne prispeva k celokupni učinkovitosti vorikonazola.
A single adverse reaction of photophobia of 10 minutes duration was reported.
Poročali so o enem samem neželenem učinku, in sicer o fotofobiji, ki je trajala 10 minut.
The inter-individual variability of voriconazole pharmacokinetics is high.
Interindividualna variabilnost farmakokinetike vorikonazola je velika.
• Breathing difficulties.
• težave z dihanjem
The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Po 180 dneh je bila stopnja preživetja 80,0 % (32/40), po 1 letu pa 70,0 % (28/40).
The primary endpoint was the rate of occurrence of proven and probable IFI during the first year after HSCT.
Primarni opazovani dogodek je bila stopnja pogostnosti dokazane in verjetne IGO v prvem letu po HSCT.
Women of child-bearing potential must always use effective contraception during treatment.
Ženske v rodni dobi Ženske v rodni dobi morajo med zdravljenjem vedno uporabljati učinkovito kontracepcijo.
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Zdravljenje se lahko začne, preden so znani izvidi kultur in drugih laboratorijskih študij; ko so ti izvidi na voljo, je treba antiinfektivno zdravljenje ustrezno prilagoditi.
The safety and efficacy of voriconazole use for longer than 180 days has not been adequately studied in clinical trials.
Varnosti in učinkovitosti uporabe vorikonazola, daljše od 180 dni, v kliničnih preskušanjih niso ustrezno raziskali.
The excretion of voriconazole into breast milk has not been investigated.
Izločanje vorikonazola v materino mleko ni raziskano.
This medicinal product must not be mixed with other medicinal products except those mentioned in section
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
As GPMT (guinea pig maximisation test) result was positive, prescribers should be aware of the hypersensitivity potential of the intravenous formulation.
Ker je bil test GPMT (maksimizacijski test pri morskih prašičkih) pozitiven, se mora predpisovalec zavedati preobčutljivostnega potenciala intravenskega pripravka.
Success rates and other secondary endpoints are presented in the table below:
Stopnje uspešnosti in drugi sekundarni opazovani dogodki so prikazani v spodnji preglednici:
Greater than proportional increase in exposure is observed with increasing dose.
Povečevanje odmerka povzroči več kot sorazmeren porast izpostavljenosti.
On the basis of the high oral bioavailability (96 %; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Glede na veliko peroralno biološko uporabnost (96 %, glejte poglavje 5.2) je menjava med intravensko in peroralno uporabo primerna, če je klinično indicirana.
This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.
To zdravilo je samo za enkratno uporabo; neuporabljeno raztopino je treba zavreči, uporabite pa lahko samo bistro raztopino brez delcev.
It is recommended to initiate the therapy with intravenous regimen, and oral regimen should be considered only after there is a significant clinical improvement.
Priporočljivo je, da zdravljenje začnemo z intravensko obliko, o peroralni uporabi pa razmislimo le po pomembnem kliničnem izboljšanju.
The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials).
Varnostni profil vorikonazola pri odraslih temelji na integrirani varnostni podatkovni bazi več kot 2.000 preskušancev (vključno s 1.603 odraslimi bolniki v terapevtskih preskušanjih in dodatnih 270 odraslih v študijah profilakse).
Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended, and the dose of anticoagulants should be adjusted accordingly.
Priporočljivo je pozorno nadziranje protrombinskega časa ali drugih primernih koagulacijskih testov in ustrezno prilagoditi odmerjanje antikoagulantov.
≤S (Susceptible)
≤S (občutljivi)
Amphotericin B → fluconazole (N=122)
amfotericin B → flukonazol (N=122)
Once reconstituted further dilution is required before administration.
Ko je raztopina rekonstituirana, je pred uporabo potrebna nadaljnja redčitev.
From a microbiological point of view, once reconstituted, the product must be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
Children and adolescents Voriconazole Hikma should not be given to children younger than 2 years of age.
Otroci in mladostniki Zdravila Vorikonazol Hikma ne smejo dobiti otroci, mlajši od 2 let.
The median duration of study drug prophylaxis was 95.5 days in the MITT group.
V skupini MITT je bila mediana trajanja profilakse s preiskovanim zdravilom 95,5 dneva.
• You are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
• imate kardiomiopatijo, nereden srčni utrip, upočasnjeno bitje srca ali nepravilnost v elektrokardiogramu (EKG), imenovano »sindrom dolgega intervala QTc«.
Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT Portugal
Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT Portugalska
Therefore, no dosage adjustment based on gender is necessary.
Zato prilagoditev odmerka glede na spol ni potrebna.
If antifungal susceptibility testing is available, the MIC results may be interpreted using breakpoint criteria established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
V primeru, da je na voljo preverjanje občutljivosti na protiglivična zdravila, je rezultate, ki se nanašajo na minimalno inhibitorno koncentracijo (MIK), mogoče interpretirati z uporabo kriterija mejne vrednosti, ki jo je ugotovil Evropski odbor za preverjanje občutljivosti na protimikrobna zdravila /European Committee on Antimicrobial Susceptibility Testing/ (EUCAST).
Currently there are insufficient data to allow dosing recommendations in this situation (see section 4.5).
Trenutno ni na voljo zadosti podatkov, ki bi omogočili priporočila o odmerjanu v tem primeru (glejte poglavje 4.5).
The ERG changes did not progress over 29 days of treatment and were fully reversible on withdrawal of voriconazole.
Spremembe ERG med 29-dnevnim zdravljenjem niso napredovale in so bile po opustitvi vorikonazola povsem reverzibilne.
Your doctor may stop the infusion if this occurs.
Če se to zgodi, lahko zdravnik ustavi infuzijo.
From all patients 58% were subject to myeloablative conditions regimens.
Pri 58 % od vseh bolnikov so izvedli mieloablativni režim.
Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Profilaksa mora biti čim krajša, trajanje pa naj bo odvisno od tveganja za pojav invazivne glivične okužbe (IGO), ki se kaže kot nevtropenija ali imunosupresija.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1004/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/15/1004/001
In rats, mice and dogs, voriconazole also induced minimal adrenal changes.
Pri podganah, miših in psih je vorikonazol povzročil tudi minimalne spremembe nadledvičnih žlez.
It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun's UV rays can occur.
Pomembno je, da pokrijete izpostavljene predele kože in uporabljate kremo za zaščito pred soncem z visokim zaščitnim faktorjem, ker se lahko pojavi povečana občutljivost kože na sončne UV žarke.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale toksičen vpliv na razmnoževanje (glejte poglavje 5.3).
The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.
Zdravnik se bo morda odločil za zmanjšanje odmerka, če imate blago do zmerno cirozo.
: Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection.
: Uspešen odziv na zdravljenje z vorikonazolom so ugotovili pri 16 (6 popolnih, 10 delnih odzivov) od 28 bolnikov, okuženih s S. apiospermum, in pri 2 (oba delna odziva) od 7 bolnikov, okuženih s S. prolificans.
The safety profile and plasma concentrations observed in male and female patients were similar.
Varnostni profil in ugotovljene koncentracije v plazmi so bili pri bolnikih in bolnicah podobni.
10 Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
10 Vključuje z zdravili povzročene poškodbe jeter, toksični hepatitis, hepatocelularne poškodbe in hepatotoksičnost.
• Allergic reaction or exaggerated immune response
• alergijske reakcije ali pretiran imunski odziv
• Very fast heart rate or skipped heartbeats, sometimes with erratic electrical impulses
• zelo hiter srčni utrip ali preskakovanje posameznih utripov, včasih z nerednimi električnimi impulzi
Careful monitoring of blood glucose is recommended.
Priporočljiv je natančen nadzor glukoze v krvi.
Standard genotoxicity and reproduction studies with the excipient SBECD reveal no special hazard for humans.
Standardne študije genotoksičnosti in reprodukcijske študije s pomožno snovjo SBECD ne kažejo posebnega tveganja za človeka.
Your doctor will determine your dose depending on your weight and the type of infection you have.
Odmerek, ki ga potrebujete, bo zdravnik določil glede na vašo telesno maso in vrsto okužbe.
1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
1 Sevi z vrednostmi MIK nad mejno vrednostjo Občutljivo (S) so redki, oziroma o njih še niso poročali.
It works by killing or stopping the growth of the fungi that cause infections.
Deluje tako, da ubije glivice, ki povzročajo okužbe, ali ustavi njihovo rast.
The second study enrolled 22 patients with invasive candidiasis including candidaemia (ICC), and esophageal candidiasis (EC) requiring either primary or salvage therapy, of whom 17 were included in the MITT efficacy analyses.
V drugo študijo so vključili 22 bolnikov z invazivno kandidozo, vključno s kandidemijo (ICC - Invasive candidiasis including candidaemia), in kandidozo požiralnika (EC - Esophageal candidiasis), ki zahteva primarno ali rešilno zdravljenje, od katerih so 17 bolnikov vključili v analize učinkovitosti MITT.
Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
S profilakso s preiskovanim zdravilom so pričeli takoj po HSCT: 224 preskušancev je prejemalo vorikonazol, 241 pa itrakonazol.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Od zdravstvenihdelavcev se zahteva, da poročajo o kateremkoli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*.
The pharmacokinetics of voriconazole have been characterised in healthy subjects, special populations and patients.
Farmakokinetika vorikonazola je bila opredeljena pri zdravih preskušancih, posebnih populacijah in bolnikih.
However, the in vitro activity of voriconazole against Candida species is not uniform.
Vendar pa in vitro delovanje vorikonazola proti vrstam Candida ni poenoteno.
Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with voriconazole and at least weekly for the first month of treatment.
Klinična obravnava mora obsegati laboratorijsko oceno delovanja jeter (zlasti AST in ALT) na začetku zdravljenja z vorikonazolom in vsaj enkrat tedensko v prvem mesecu zdravljenja.
In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medicinal product was defined as resolution/improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites at 12 weeks after the end of therapy (EOT).
V primarni analizi je bil uspešen odziv (kot ga je ocenil Odbor za pregled podatkov [OPP], slepljen za proučevano zdravilo) opredeljen kot izginotje/izboljšanje vseh kliničnih znakov in simptomov okužbe ter odstranitev Candide iz krvi in okuženih mest v globokih tkivih 12 tednov po koncu terapije (KT).
Pregnancy There are no adequate data on the use of voriconazole in pregnant women available.
Nosečnost O uporabi vorikonazola pri nosečnicah ni na voljo dovolj podatkov.
The overall rate of response (ICC and EC combined) was 88.9% (8/9) for 2 to <12 years old and 62.5% (5/8) for 12 to <18 years old.
Celokupna stopnja odziva (ICC in EC skupaj) je bila 88,9 % (8/9) za skupino, staro od 2 do < 12 let, in 62,5 % (5/8) za skupino, staro od 12 do < 18 let.