natgillin/translations-raw huggingface dataset:
In addition, SevoFlo has been commonly used off-label (use that is not officially authorised) as an anaesthetic for cats for more than 10 years and therefore its use in cats is considered to be ‘well-established'.
Osim toga, SevoFlo se uobičajeno primjenjuje bez službenog odobrenja kao anestetik za mačke već više od 10 godina i stoga se smatra da je njegova primjena kod mačaka „provjerena”.
SevoFlo produced a relatively rapid and smooth start of anaesthesia in dogs, followed by a good recovery.
SevoFlo je proizveo relativno brz i neometan početak anestezije u pasa te naknadno dobar oporavak.
SevoFlo is used to bring about and maintain general anaesthesia (loss of consciousness).
SevoFlo se koristi za davanje i održavanje opće anestezije (gubitka svijesti).
Other information about SevoFlo
Ostale informacije o VMP-u SevoFlo
Why is SevoFlo authorised in the EU?
Zašto je SevoFlo odobren u EU-u?
This is a rare life-threatening condition usually triggered by exposure to certain general anaesthetics that is associated with muscle spasm and very high body temperatures.
To je rijetko, ali za život opasno stanje, koje obično nastaje zbog izloženosti određenim općim anesteticima i koje je povezano s grčenjem mišića i vrlo visokim tjelesnim temperaturama.
Sevoflurane mimics the action of GABA, a substance that naturally reduces brain activity, and blocks the action of glutamate, which stimulates the activity of the brain.
Sevofluran oponaša djelovanje tvari GABA koja prirodno smanjuje aktivnost mozga i blokira djelovanje glutamata koji potiče aktivnost mozga.
If a person accidentally inhales sevoflurane vapour, this may cause symptoms such as shivering, nausea, headache, low blood pressure, decreased heart rate and even reduced breathing.
Ako osoba slučajno udahne paru sevoflurana, to može izazvati simptome kao što su drhtanje, mučnina, glavobolja, nizak krvni tlak, snižen broj otkucaja srca pa čak i ograničeno disanje.
SevoFlo is a general anaesthetic for dogs and cats.
SevoFlo je opći anestetik za pse i mačke.
The most common side effects with SevoFlo, which may affect more than 1 in 10 animals, are low blood pressure, rapid breathing, muscle tenseness, excitation, a temporary inability to breathe, small muscle twitches and vomiting.
Najčešće nuspojave povezane s primjenom VMP-a SevoFlo, koje se mogu pojaviti u 1 na 10 životinja, jesu nizak krvni tlak, brzo disanje, napetost mišića, ekscitacija, privremena nesposobnost disanja, mali mišićni trzaji i povraćanje.
Care must therefore be taken when handling SevoFlo: any spillage must be removed immediately, the vapour must not be inhaled, and any contact with the product by mouth must be avoided.
Stoga se mora pozorno rukovati VMP-om SevoFlo: ako se prolije, mora se odmah ukloniti, para se ne smije udahnuti te se mora izbjegavati bilo kakav kontakt s ustima.
The European Medicine's Agency decided that SevoFlo's benefits are greater that its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od VMP-a SevoFlo nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
The dog or cat breathes in the gas mixture, which causes it to become unconscious.
Pas ili mačka udišu smjesu plinova koja uzrokuje njihovu nesvijest.
What are the risks associated with SevoFlo?
Koji su rizici povezani s VMP-om SevoFlo?
Studies in dogs found that SevoFlo was as effective at starting and maintaining anaesthesia as other anaesthetic agents, such as isoflurane (another anaesthetic gas), thiopental, propofol, and ketamine plus diazepam.
U ispitivanjima provedenima na psima utvrđeno je da je VMP SevoFlo bio jednako djelotvoran na početku anestezije i u njezinu održavanju kao ostala sredstva za anesteziju, kao što je isofluran (još jedan anestetski plin), tiopental, propofol i ketamin s diazepamom.
Pregnant and breast-feeding women must not come into contact with the product and they should also avoid operating rooms and animal recovery areas where the product is being used or has recently been used.
Trudnice i dojilje ne smiju doći u dodir s VMP-om te moraju izbjegavati operacijske dvorane i prostore za oporavak životinja u kojima se VMP primjenjuje ili je nedavno primjenjivan.
It contains the active substance sevoflurane, a chemical which is a liquid at room temperature, but when heated becomes a gas (vaporises).
Sadržava djelatnu tvar sevofluran, kemikaliju koja je tekuća pri sobnoj temperaturi, ali zagrijana prelazi u plinovito stanje (isparava).
An overview of SevoFlo and why it is authorised in the EU
Pregled VMP-a SevoFlo i zašto je odobren u EU-u
SevoFlo received a marketing authorisation valid throughout the EU for SevoFlo on 11 December
SevoFlo je dobio odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 11. prosinca
Studies showed that sevoflurane could be used safely with several other medicines commonly used in dogs before or during operations, for maintenance of anaesthesia.
Ispitivanja su pokazala da se sevofluran može sigurno primjenjivati s nekoliko drugih VMP-ova koji se uobičajeno primjenjuju kod pasa prije ili tijekom operacija za održavanje anestezije.
How does SevoFlo work?
Kako djeluje SevoFlo?
What benefits of SevoFlo have been shown in studies?
Koje su koristi od VMP-a SevoFlo utvrđene u ispitivanjima?
For more information about using SevoFlo, see the package leaflet or contact your veterinarian or pharmacist.
Više informacija o primjeni VMP-a SevoFlo pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
Safety information has been included in the summary of product characteristics and the package leaflet for SevoFlo, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
U sažetku opisa svojstava VMP-a, kao i u uputi o VMP-u SevoFlo, nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
For the full list of side effects of SevoFlo, and for the full list of restrictions, see the package leaflet.
Potpuni popis svih nuspojava zabilježenih prilikom primjene VMP-a SevoFlo te potpuni popis ograničenja potražite u uputi o VMP-u.
How is SevoFlo used?
Kako se SevoFlo koristi?
For cats, a review of published scientific literature showed that SevoFlo is effective for anaesthesia and that it is compatible with a range of sedative and pain-relieving medicines used in anaesthesia.
djelotvoran za anesteziju i da je kompatibilan s nizom sedativnih VMP-ova i VMP-ova za ublažavanje boli koji se upotrebljavaju u anesteziji.
See Table 5 and 6 for results from both studies.
Vidjeti Tablice 5 i 6 za rezultate iz oba ispitivanja.
1 Includes other less common species or species unknown
1Obuhvaća ostale rjeđe vrste ili nepoznate vrste
- If you have any suspension left in a bottle more than 30 days after it was first opened, you should not use this medicine.
- Ako je u boci ostalo još nešto suspenzije više od 30 dana nakon prvog otvaranja, ne smijete više koristiti ovaj lijek.
Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2 međutim nije moguće dati preporuku o doziranju.
After first opening the container: 30 days
Nakon prvog otvaranja spremnika: 30 dana
● Risk Management Plan (RMP)
PRIMJENU LIJEKA Plan upravljanja rizikom (RMP)
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1380/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1380/001
H-1045 Budapest Hungary
H-1045 Budimpešta
Accord Healthcare Polska Sp. z o.o.
Accord Healthcare Polska Sp. z o.o. ul.
§ See section 4.4.
§ Vidjeti dio 4.4
Do not adapt your dose yourself before consulting your doctor or change your treatment regime.
Nemojte sami sebi prilagođavati dozu ili mijenjati svoj režim liječenja prije savjetovanja s liječnikom.
Bottles showing any visible settling should be vigorously shaken for a minimum of 10 seconds.
Bočice s vidljivim taloženjem potrebno je snažno protresti najmanje 10 sekundi.
- if you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
- ako dobijete teški proljev ili povraćate, jer ta stanja mogu ograničiti učinkovitost ovog lijeka;
Children Posaconazole AHCL should not be used in children (17 years of age and younger).
Posakonazol AHCL se ne smije primjenjivati u djece (u dobi od 17 godina i mlađe).
- a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.
- „statin” kao što je simvastatin, atorvastatin ili lovastatin koji se primjenjuju za liječenje visokog kolesterola.
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, Spain
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, Španjolska
Effect of food on oral absorption in healthy volunteers
Utjecaj hrane na apsorpciju nakon peroralne primjene u zdravih dobrovoljaca
To improve absorption of posaconazole, whenever possible it should be taken during or immediately after food or a nutritional drink (see section 3 “How to take Posaconazole AHCL”).
Kako bi se poboljšala apsorpcija posakonazola, treba ga, kad god je moguće, uzimati tijekom ili neposredno nakon obroka ili nutritivnog napitka (vidjeti dio 3 „Kako uzimati Posakonazol AHCL“).
EXP Discard after 30 days of opening.
EXP Baciti po isteku 30 dana nakon otvaranja.
You should not take this medicine if you have a condition called glucose-galactose malabsorption and should take note of this amount of glucose if you need to watch your sugar intake for any reason.
Nemojte uzimati ovaj lijek ako imate poremećaj malapsorpcije glukoze i galaktoze, a trebate uzeti u obzir ovu količinu glukoze ako iz bilo kojeg razloga morate kontrolirati unos šećera.
The filled and sealed bottle is packed into a carton along with a graduated polystyrene spoon (2.5 mL and 5 mL) for dispensing and administration of the suspension.
Napunjena i zatvorena boca pakirana je u kartonsku kutiju zajedno sa žličicom od graduiranog polistirena (od 2,5 ml i 5 ml) za doziranje i primjenu suspenzije.
Pharmacokinetic / Pharmacodynamic relationships A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Farmakokinetički/farmakodinamički odnosi Opažena je korelacija između ukupne izloženosti lijeku podijeljene s najmanjom inhibitornom koncentracijom (AUC/MIK) i kliničkog ishoda.
However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
randomizirano, kontrolirano ispitivanje, svaku se usporedbu s vanjskom kontrolnom skupinom mora razmotriti uz oprez.
In Study 316, overall mortality was similar (POS, 25 %; FLU, 28 %); however, the proportion of IFIrelated deaths was significantly lower in the POS group (4/301) compared with the FLU group (12/299; P= 0.0413).
Ispitivanju 316 utvrđen je sličan ukupni mortalitet (POS, 25%; FLU, 28%); međutim, udio smrti povezanih s IGI bio je značajno niži u skupini koja je uzimala POS (4/301) nego u skupini koja je primala FLU (12/299; p=0,0413).
Your doctor will monitor your response and condition to determine how long Posaconazole AHCL needs to be given and whether any change is needed to your daily dose.
Liječnik će pratiti Vaš odgovor na liječenje i Vaše stanje kako bi odredio koliko dugo morate uzimati Posakonazol AHCL i jesu li potrebne neke promjene dnevne doze.
The duration of therapy is based on recovery from neutropenia or immunosuppression.
Trajanje liječenja temelji se na oporavku od neutropenije ili imunosupresije.
- Do not use this medicine after the expiry date which is stated on the label.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake
Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Uspjeh prema vrstama uzročnika Sve mikološki potvrđene vrste roda Aspergillus1
Posaconazole is slowly eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).
Posakonazol se sporo eliminira, uz srednji poluvijek (t½) od 35 sati (raspon: 20 do 66 sati).
Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomization, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P= 0.0354) as well as IFI-related deaths (P = 0.0209).
Na temelju KaplanMeierovih procjena, vjerojatnost preživljenja do 100. dana nakon randomizacije bila je značajno veća u bolesnika koji su primali posakonazol; taj se koristan utjecaj na preživljenje pokazao kada je analiza obuhvatila sve uzroke smrti (p=0,0354) kao i smrti povezane s invazivnim gljivičnim infekcijama (p=0,0209).
The following medicines may decrease the effectiveness of Posaconazole AHCL by decreasing the amount of Posaconazole AHCL in the blood: - rifabutin and rifampicin (used to treat certain infections).
Sljedeći lijekovi mogu smanjiti učinkovitost lijeka Posakonazol AHCL tako što smanjuju njegovu količinu u krvi: - rifabutin i rifampicin (primjenjuju se za liječenje nekih infekcija).
There is no information on the effect of alcohol on posaconazole."
Nema podataka o utjecaju alkohola na posakonazol.
Opening date:_________
Datum otvaranja:
White to off-white free flowing suspension.
OBLIK Oralna suspenzija Bijela do bjelkasta suspenzija.
The majority (377/600, [63 %]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5%]) GVHD at study start.
Većina uključenih bolesnika (377/600, [63%]) je na početku ispitivanja imala akutni GVHD stupnja 2 ili 3 ili kronični opsežni GVHD (195/600, [32,5%]).
Look at the list of medicines given above that must not be taken while you are taking Posaconazole AHCL.
Pročitajte gore navedeni popis lijekova koji se ne smiju uzimati dok uzimate Posakonazol AHCL.
Elderly (≥ 65 years) An increase in Cmax (26 %) and AUC (29 %) was observed in elderly subjects (24 subjects ≥ 65 years of age) relative to younger subjects (24 subjects 18 - 45 years of age).
Stariji (65 godina) Opažen je porast Cmax (26%) i AUC-a (29%) u starijih ispitanika (24 ispitanika 65 godina) u odnosu na mlađe ispitanike (24 ispitanika u dobi 18-45 godina).
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 AHCL.
Pored gore navedenih lijekova postoje i drugi lijekovi koji nose rizik od nastanka poteškoća sa srčanim ritmom, koji se može povećati ako se uzimaju s lijekom Posakonazol AHCL.
Tabulated list of adverse reactions Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Unutar klasifikacije organskih sustava, nuspojave su navedene prema učestalosti pojavljivanja definiranoj kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko
For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole AHCL should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
U bolesnika s akutnom mijeloičnom leukemijom ili mijelodisplastičnim sindromima profilaksu lijekom Posakonazol AHCL treba započeti nekoliko dana prije očekivanog nastupa neutropenije i nastaviti još 7 dana nakon što broj neutrofila poraste na više od 500 stanica po mm3.
What Posaconazole AHCL looks like and contents of the pack Posaconazole AHCL is a white to off-white free flowing suspension, packaged in amber glass bottle.
Kako Posakonazol AHCL izgleda i sadržaj pakiranja Posakonazol AHCL je bijela do bjelkasta suspenzija, pakirana u smeđoj (jantarnoj) staklenoj boci.
Food The absorption of posaconazole is significantly increased by food (see sections 4.2 and 5.2).
Hrana značajno povećava apsorpciju posakonazola (vidjeti dijelove 4.2 i 5.2).
The table below shows the recommended dose and length of treatment which depend on the type of infection that you have and may be individually adapted for you by your doctor.
Tablica ispod prikazuje preporučene doze i trajanje liječenja, koje ovise o vrsti infekcije koju imate i
- infections in the mouth or throat area (known as “thrush”) caused by fungi called Candida, which were not previously treated.
- infekcija u području usta ili grla (tzv. „mliječac“) prouzročenih gljivicom Candida, koje nisu prethodno liječene.
There is no special treatment available in the case of overdose with posaconazole.
Nema posebnog dostupnog liječenja u slučaju predoziranja posakonazolom.
Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group
Ukupna djelotvornost posakonazol oralne suspenzije na završetku liječenja invazivne aspergiloze u usporedbi s vanjskom kontrolnom skupinom Posakonazol oralna suspenzija
Do not take Posaconazole AHCL if any of the above apply to you.
Nemojte uzimati Posakonazol AHCL ako se nešto od gore navedenog odnosi na Vas.
The elimination half-life (t1/2) was prolonged from approximately 27 hours up to ~43 hours in respective groups.
Poluvijek eliminacije (t½) je u odgovarajućim skupinama produljen sa približno 27 sati na ~ 43 sata.
Therefore, trough concentrations that fall in the upper part of the usual therapeutic range should be targeted and careful attention should be paid to clinical signs and symptoms, laboratory parameters and tissue biopsies.
Stoga treba ciljati da najniža koncentracija sirolimusa bude u gornjem dijelu uobičajenog raspona terapijskih vrijednosti, te u tom smislu treba pomno pratiti kliničke znakove i simptome, laboratorijske nalaze i nalaze biopsije tkiva.
At exposures lower than those obtained at therapeutic doses in humans, posaconazole caused skeletal variations and malformations, dystocia, increased length of gestation, reduced mean litter size and postnatal viability.
Pri izloženosti manjoj od one koja se postiže terapijskim dozama u ljudi posakonazol je prouzročio koštane varijacije i malformacije, distociju, produljeno trajanje gestacije, smanjenu srednju veličinu okota i smanjenu sposobnost postnatalnog preživljavanja.
Posaconazole AHCL contains approximately 1.75g of glucose per 5mLof suspension.
Posakonazol AHCL sadrži približno 1,75 g glukoze u 5 ml suspenzije.
Posaconazole AHCL with food and drink
Posakonazol AHCL s hranom i pićem
After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Nakon primjene 14C-posakonazola, radioaktivnost se uglavnom otkrila u stolici (77% radioaktivno označene doze), a glavnu je komponentu činio izvorni spoj (66% radioaktivno označene doze).
Posaconazole is also available as 100 mg gastro-resistant tablet and 300 mg concentrate for solution for infusion.
Posakonazol je također dostupan u obliku želučanootpornih tableta od 100 mg i koncentrata za otopinu za infuziju od 300 mg.
Do not take Posaconazole AHCL if you are pregnant unless you are told to by your doctor.
Nemojte uzeti Posakonazol AHCL ako ste trudni, osim ako
The critical ratio for subjects with Aspergillus infections was ~200.
Kritična vrijednost navedenog omjera za ispitanike s infekcijama čiji je uzročnik bio Aspergillus iznosila je ~200.
Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz and cimetidine
Rifamicinski antibiotici (rifampicin, rifabutin), određeni antikonvulzivi (fenitoin, karbamazepin, fenobarbital, primidon), efavirenz i cimetidin
- Candida albicans: S ≤0.06 mg/L, R >0.06 mg/L - Candida tropicalis: S ≤0.06 mg/L, R >0.06 mg/L - Candida parapsilosis: S ≤0.06 mg/L, R >0.06 mg/L
(R)], su: - Candida albicans: S ≤0,06 mg/l, R >0,06 mg/l - Candida tropicalis: S ≤0,06 mg/l, R >0,06 mg/l
No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Nisu opažene klinički značajne promjene srednje vrijednosti QTc-intervala (Fridericia) u odnosu na početne vrijednosti.
Caution should be used when prescribing Posaconazole AHCL to patients with hypersensitivity to other azoles.
Potreban je oprez kad se Posakonazol AHCL propisuje bolesnicima preosjetljivima na druge azole.
If these medicinal products are co-administered, careful monitoring of full blood counts and adverse reactions related to increased rifabutin levels (e.g. uveitis) is recommended.
Ako se ovi lijekovi primjenjuju istodobno, preporučuje se pomno nadzirati kompletnu krvnu sliku kao i nuspojave povezane s povećanom koncentracijom rifabutina (npr. uveitis).
This medicine contains less than 1 mmol sodium (23 mg) per 5 mL of suspension, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 5 ml suspenzije, tj. zanemarive količine natrija.
In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/304 (16 %) vs. FLU/ITZ 67/298 (22 %) p= 0.048].
1899d 316d posakonazola [POS 49/304 (16%) naspram FLU/ITZ 67/298 (22%) p=0,048].
In a study in healthy volunteers posaconazole oral suspension (200 mg once daily for 10 days) increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83 %.
U jednom ispitivanju u zdravih dobrovoljaca, posakonazol oralna suspenzija (200 mg jedanput na dan tijekom 10 dana) povećala je izloženost (AUC) intravenski primijenjenog midazolama (0,05 mg/kg) za 83%.
Do not switch between taking Posaconazole tablets and posaconazole oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.
Nemojte prijeći s tableta posakonazola na oralnu suspenziju posakonazola ili obrnuto bez razgovora s liječnikom ili ljekarnikom jer to može dovesti do smanjenja djelotvornosti lijeka i povećanog rizika za pojavu nuspojava.
There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea).
Gastrointestinalna disfunkcija Farmakokinetički podaci u bolesnika s teškom gastrointestinalnom disfunkcijom (npr. jakim proljevom) su ograničeni.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of oral suspension contains 40 mg of posaconazole.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml oralne suspenzije sadrži 40 mg posakonazola.
Posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Rifabutin Posakonazol je povećao Cmax rifabutina za 31%, a AUC za 72%.
Patients were treated with posaconazole or fluconazole oral suspension (both posaconazole and fluconazole were given as follows: 100 mg twice a day for 1 day followed by 100 mg once a day for 13 days).
Bolesnici su liječeni posakonazolom ili flukonazolom u obliku oralne suspenzije (oba lijeka posakonazol i flukonazol su se primjenjivala na sljedeći način: 100 mg dvaput na dan 1. dana, a nakon toga 100 mg jedanput na dan tijekom 13 dana).
In subjects with severe renal impairment (n=6, Cl cr< 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96 % CV (coefficient of variance)] compared to other renal groups [< 40 % CV].
U ispitanika s teškim oštećenjem funkcije bubrega (n=6, CIcr<20 ml/min/1,73 m2), AUC posakonazola jako je varirao [>96% CV (koeficijent varijabilnosti)] u usporedbi s drugim kategorijama bubrežne funkcije [<40% CV].
Discard after 30 days of opening.
Baciti po isteku 30 dana nakon otvaranja.
Each dose of Posaconazole AHCL 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.
Svaka doza lijeka Posakonazol AHCL mora se primijeniti tijekom ili neposredno nakon obroka, odnosno nadomjeska prehrani u bolesnika koji ne podnose hranu, kako bi se poboljšala oralna apsorpcija i osigurala primjerena izloženost lijeku.