natgillin/translations-raw huggingface dataset:
In an oral multiple-dose study Cmax and AUCτ in healthy elderly males (≥65 years) were 61% and 86% higher, respectively, than in healthy young males (18-45 years).
U jednom ispitivanju s višekratnom primjenom peroralne doze lijeka Cmax je u zdravih starijih muškaraca bio je 61% veći, a AUCτ 86% veći nego u zdravih mladih muškaraca (18-45 godina).
VFEND 200 mg powder for solution for infusion and VFEND 200 mg powder and solvent for solution for infusion:
VFEND 200 mg prašak za otopinu za infuziju i VFEND 200 mg prašak i otapalo za otopinu za infuziju:
Solvent for solution for infusion: Clear diluent solution.
Otapalo za otopinu za infuziju: Prozirna otopina za razrjeđivanje.
VFEND is also available as 50 mg and 200 mg film-coated tablets, 200 mg powder for solution for injection and 200 mg powder and solvent for solution for infusion.
VFEND je dostupan i u obliku filmom obloženih tableta od 50 mg i 200 mg, praška za otopinu za injekciju od 200 mg i praška i otapala za otopinu za infuziju od 200 mg.
Dose reduction of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered.
Treba razmotriti smanjenje doze alfentanila, fentanila i drugih opijata kratkog djelovanja strukturno sličnih alfentanilu koji se metaboliziraju pomoću CYP3A4 (npr. sufentanil).
200 mg twice a day
200 mg dvaput na dan
In an oral multiple-dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher, respectively, than in healthy young males (18-45 years).
U ispitivanju s višekratnom primjenom peroralne doze lijeka Cmax je u zdravih mladih žena bio 83% veći, a AUCτ 113% veći nego u zdravih mladih muškaraca (18-45 godina).
VFEND must not be infused into the same line or cannula concomitantly with other intravenous products.
VFEND se ne smije infundirati istodobno s drugim lijekovima u istoj infuzijskoj liniji ili kanili.
Step 7
Korak 7
Other oral coumarins (e.g., phenprocoumon, acenocoumarol) [CYP2C9 and CYP3A4 substrates]
Drugi kumarinski lijekovi koji se uzimaju peroralno (npr. fenprokumon, acenokumarol) [supstrati CYP2C9 i CYP3A4]
400 mg every 12 hours for the first 24 hours
400 mg svakih 12 sati tijekom prva 24 sata
It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole (see section 5.2).
Preporučuje se da se u bolesnika s blagom do umjerenom cirozom jetre (Child-Pughov stadij A i B) koji dobivaju vorikonazol liječenje započne standardnom udarnom dozom, no da se doza održavanja prepolovi (vidjeti dio 5.2).
Ensure the internal spike of the vial adaptor is placed at the centre of the vial septum and push the adaptor firmly onto the vial until it snaps into place.
Provjerite je li unutarnji šiljak na nastavku za bočicu smješten na sredini čepa bočice i čvrsto pritisnite nastavak na bočicu dok ne sjedne na mjesto.
Step 4
Korak 4
Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID
Efavirenz 400 mg QD, primijenjeno istodobno s vorikonazolom u dozi od 200 mg BID
Rifabutin [potent CYP450 inducer]
Rifabutin [snažan induktor CYP450]
Powder for solution for infusion 1 vial
Prašak za otopinu za infuziju 1 bočica
VFEND 200 mg powder for solution for infusion Powder for solution for infusion:White lyophilised powder.
VFEND 200 mg prašak za otopinu za infuziju Prašak za otopinu za infuziju; Bijeli liofilizirani prašak.
The powder is reconstituted with either 19 ml of water for injections or 19 ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole.
Prašak se priprema za primjenu ili s 19 ml vode za injekcije ili s 19 ml otopine natrijevog klorida za infuziju od 9 mg/ml (0,9%), kako bi se dobio iskoristivi volumen od 20 ml bistrog koncentrata koji sadrži 10 mg/ml vorikonazola.
• Ritonavir (used for treating HIV) in doses of 400mg and more twice daily
• ritonavir (koristi se za liječenje HIV-a) u dozama od 400 mg i više dva puta na dan
VFEND tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
300 mg QD (coadministered with voriconazole 350 mg BID)
300 mg QD (primijenjeno istodobno s vorikonazolom u dozi od 350 mg BID)
Instructions to constitute the suspension:
Upute za pripremu suspenzije:
Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Preporučuje se nadzor kako bi se uočile nuspojave povezane s vorikonazolom ako se vorikonazol primjenjuje nakon liječenja flukonazolom.
Voriconazole (N=248)
Vremenska točka Vorikonazol (N=248)
200 mg (5 ml) every 12 hours
200 mg (5 ml) svakih 12 sati
One 100 ml high-density polyethylene (HDPE) bottle (with a polypropylene child resistant closure) contains
Boca od polietilena visoke gustoće (HPDE) volumena 100 ml (s polipropilenskim sigurnosnim zatvaračem za djecu) koja sadrži 45 g praška za oralnu suspenziju.
Each bag contains 50 ml of sodium chloride 0.9% in Water for Injections.
Jedna vrećica sadrži 50 ml otopine natrijevog klorida od 9 mg/ml (0,9%) u vodi za injekcije.
1 vial of VFEND powder for solution for infusion (single use vial) 1 overwrap
1 bočicu VFEND praška za otopinu za infuziju (bočica za jednokratnu uporabu) 1 infuzijsku vrećicu
Your doctor should also monitor your liver function while you are being treated with VFEND by doing blood tests.
Za vrijeme liječenja lijekom VFEND liječnik također mora nadzirati funkciju Vaše jetre putem krvnih pretraga.
Shake the closed bottle of constituted suspension for approximately 10 seconds before use.
Prije uporabe protresite zatvorenu bocu s pripremljenom suspenzijom desetak sekundi.
Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract causing antibiotic associated diarrhoea, inflammation of the lymphatic vessels Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ
- simptomi nalik gripi, nadraženost i upala probavnog trakta, upala probavnog trakta koja uzrokuje proljev povezan uz antibiotike, upala limfnih žila - upala tankog tkiva kojim je obložena unutarnja stijenka trbuha i koja prekriva trbušne organe,
Tell your doctor if you experience this.
Obavijestite svog liječnika ako imate te nuspojave.
VFEND 40 mg/ml powder for oral suspension voriconazole
VFEND 40 mg/ml prašak za oralnu suspenziju vorikonazol
VFEND is also available as 50 mg and 200 mg film-coated tablets and 40 mg/ml powder for oral suspension.
VFEND je dostupan i u obliku filmom obloženih tableta od 50 mg i 200 mg i praška za oralnu suspenziju od 40 mg/ml.
Step 6
Korak 6
In an independent published study, Sirolimus Cmax  6.6-fold Sirolimus AUC0-  11-fold
Sirolimus Cmax  6,6 puta Sirolimus AUC0-∞  11 puta
Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID
Efavirenz 300 mg QD, primijenjeno istodobno s vorikonazolom u dozi od 400 mg BID
Use of voriconazole in prophylaxis for greater than 180 days (6 months) requires careful assessment of the benefit-risk balance (see sections 4.4 and 5.1).
Upotreba vorikonazola u profilaksi duže od 180 dana (6 mjeseci) zahtijeva temeljitu procjenu omjera koristi i rizika (vidjeti dijelove 4.4 i 5.1).
VFEND contains lactose
VFEND sadrži laktozu
• Ritonavir (used for treating HIV) in doses of 100 mg twice daily
• ritonavir (koristi se za liječenje HIV-a) u dozi od 100 mg dva puta na dan
Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported with the use of voriconazole.
Kod primjene vorikonazola prijavljene su teške kožne nuspojave (engl. severe cutaneous adverse reactions, SCARs), poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i reakcije na lijek s eozinofilijom i sistemskim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS), koje mogu biti opasne po život ili smrtonosne.
VFEND 50 mg film-coated tablets
VFEND 50 mg filmom obložene tablete
VFEND contains the active substance voriconazole.
VFEND sadrži djelatnu tvar vorikonazol.
Blood and lymphatic system disorders agranulocytosis pancytopenia, thrombocytopenia leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Poremećaji krvi i limfnog sustava agranulocitoza pancitopenija, trombocitopenija leukopenija, anemija zatajenje koštane srži, limfadenopatija, eozinofilija diseminirana intravaskularna koagulacija
• Not for administration as a bolus injection.
• Nije za primjenu u obliku bolusne injekcije.
Each kit is for single use only.
Jedna bočica je samo za jednokratnu uporabu.
4 Gently invert the vial.
4 Nježno preokrenite bočicu.
The oral maintenance dose of 200 mg (or 100 mg for patients less than 40 kg) achieves a voriconazole exposure similar to 3 mg/kg IV. A 300 mg (or 150 mg for patients less than 40 kg) oral maintenance dose achieves an exposure similar to 4 mg/kg IV.
Peroralnom dozom održavanja od 200 mg (ili 100 mg za bolesnike tjelesne težine manje od 40 kg) postiže se podjednaka izloženost vorikonazolu kao kod intravenske primjene doze od 3 mg/kg.
Voriconazole Cmax  104% Voriconazole AUC  87%
Vorikonazol Cmax  104% Vorikonazol AUC  87%
200 mg (5 ml) twice a day
200 mg (5 ml) dvaput na dan
Long term exposure to voriconazole greater than 180 days (6 months) requires careful assessment of the benefit-risk balance (see sections 4.4 and 5.1).
Dugotrajno izlaganje vorikonazolu duže od 180 dana (6 mjeseci) zahtijeva temeljitu procjenu koristi i rizika (vidjeti dijelove 4.4 i 5.1).
Once reconstituted, VFEND should be used immediately, but if necessary may be stored for up to 24 hours at 2°C - 8°C (in a refrigerator).
VFEND se mora primijeniti odmah nakon pripreme, no, ako je neophodno, može se čuvati najdulje 24 sata na temperaturi od 2°C do 8°C (u hladnjaku).
Powder and solvent for solution for infusion Each pack contains:
VFEND prašak i otapalo za otopinu za infuziju isporučuje se u kompletu za primjenu lijeka koji sadrži:
The predicted total exposures in children following IV maintenance doses of 4 and 8 mg/kg twice daily were comparable to those in adults following 3 and 4 mg/kg IV twice daily, respectively.
Predviđena ukupna izloženost u djece nakon i.v. primjene doze održavanja od 4 mg/kg dvaput na dan bila je usporediva s onom u odraslih nakon i.v. primjene 3 mg/kg dvaput na dan, dok je izloženost u djece nakon i.v. primjene doze održavanja od 8 mg/kg dvaput na dan bila usporediva s onom u odraslih nakon i.v. primjene doze od 4 mg/kg dvaput na dan.
VFEND 200 mg film-coated tablets
VFEND 200 mg filmom obložene tablete
Efavirenz (a non-nucleoside reverse transcriptase inhibitor) [CYP450 inducer; CYP3A4 inhibitor and substrate]
Efavirenz (nenukleozidni inhibitor reverzne transkriptaze) [induktor CYP450; inhibitor i supstrat CYP3A4]
Immunosuppressants [CYP3A4 substrates]
Imunosupresivi [supstrati CYP3A4]
Also contains sucrose.
Lijek sadrži i saharozu.
Voriconazole has been associated with cases of serious hepatic toxicity in patients with other serious underlying conditions.
U bolesnika s drugim ozbiljnim osnovnim bolestima liječenje vorikonazolom se povezivalo sa slučajevima ozbiljne hepatotoksičnosti.
100 mg (2.5 ml) twice a day
100 mg (2,5 ml) dvaput na dan
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODACI KOJI SE MORAJU NAVESTI NA VANJSKOM I UNUTARNJEM PAKIRANJU
Step 3
Korak 3
Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Blister pakiranje za 50 mg filmom obložene tablete - pakiranje od 2, 10, 14, 20, 28, 30, 50, 56, 100
400 mg (10 ml) every 12 hours
400 mg (10 ml) svakih 12 sati
6 mg/kg every 12 hours
6 mg/kg svakih 12 sati
Blister pack for 200 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Blister pakiranje za 200 mg filmom obložene tablete - pakiranje od 2, 10, 14, 20, 28, 30, 50, 56, 100
Each tablet contains 50 mg voriconazole.
Jedna tableta sadrži 50 mg vorikonazola.
VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets Voriconazole
VFEND 50 mg filmom obložene tablete VFEND 200 mg filmom obložene tablete vorikonazol
1b To prepare the IV vial for reconstitution, remove the plastic cap from the vial and wipe the top with an antiseptic swab.
Nemojte skidati vanjski zaštitni kalup. 1b Kako biste bočicu za i.v. primjenu pripremili za rekonstituciju, skinite plastični zatvarač i prebrišite vrh bočice vatom sa sredstvom za dezinfekciju.
From a microbiological point of view, once reconstituted, the product must be used immediately.
S mikrobiološkog stanovišta, lijek se mora primijeniti odmah nakon pripreme.
Coadministration of voriconazole and sirolimus is contraindicated (see section
Istodobna primjena vorikonazola i sirolimusa je kontraindicirana (vidjeti dio 4.3).
VFEND 200 mg film-coated tablets are supplied as white to off-white capsule shaped film-coated tablets with Pfizer marked on one side and VOR200 on the reverse.
VFEND 200 mg filmom obložene tablete su bijele do gotovo bijele filmom obložene tablete u obliku kapsule, s utisnutom oznakom "Pfizer" na jednoj i "VOR200" na suprotnoj strani.
Prednisolone Cmax  11% Prednisolone AUC0-  34%
Prednizolon Cmax  11% Prednizolon AUC0-∞  34%
Developed proven or probable
Nastala dokazana ili vjerojatna invazivna gljivična infekcija do
400 mg every 12 hours
400 mg svakih 12 sati
Excipient: sulfobutylether beta cyclodextrin sodium.
Pomoćne tvari: natrijev sulfobutileter beta-ciklodekstrin.
• If you have any further questions, ask your doctor, pharmacist or nurse.
- Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
200 mg every 12 hours
200 mg svakih 12 sati
Voriconazole Cmax  93% Voriconazole AUC  96%
Vorikonazol Cmax  93% Vorikonazol AUC  96%
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
Dokazana je i aktivnost in vitro protiv patogena iz rodova Curvularia i Sporothrix, no klinički značaj tog nalaza nije poznat.
EXP Any remaining suspension should be discarded 14 days after constitution.
Rok valjanosti Sva preostala suspenzija treba se zbrinuti 14 dana nakon pripreme.
VFEND is also available as 200 mg powder for solution for infusion, 200 mg powder and solvent for solution for infusion and 40 mg/ml powder for oral suspension.
VFEND je dostupan i u obliku praška za otopinu za infuziju od 200 mg, praška i otapala za otopinu za infuziju od 200 mg i praška za oralnu suspenziju od 40 mg/ml.
Expiry date of the constituted suspension:
Rok valjanosti pripremljene suspenzije:
Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Poremećaji jetre i žuči abnormalne vrijednosti testova funkcije jetre žutica, žutica kolestatska, hepatitis zatajenje jetre, hepatomegalija, kolecistitis, kolelitijaza
VFEND 50 mg film-coated tablets are supplied as white to off-white round film-coated tablets with Pfizer marked on one side and VOR50 on the reverse.
VFEND 50 mg filmom obložene tablete su bijele do gotovo bijele, okrugle filmom obložene tablete s utisnutom oznakom "Pfizer" na jednoj i "VOR50" na suprotnoj strani.
Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg IV BID or from 200 mg to 400 mg oral BID (100 mg to 200 mg oral BID in patients less than 40 kg) (see section 4.2).
Fenitoin se može primjenjivati istodobno s vorikonazolom ako se doza održavanja vorikonazola povisi na 5 mg/kg BID intravenski, ili s 200 mg na 400 mg BID peroralno (sa 100 mg na 200 mg BID peroralno u bolesnika s manje od 40 kg) (vidjeti dio 4.2).
Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Fenitoin se smije istodobno primijeniti s vorikonazolom ako se doza održavanja vorikonazola poveća s 200 mg na 400 mg peroralno, dvaput na dan (100 mg na 200 mg peroralno, dvaput na dan u bolesnika tjelesne težine manje od 40 kg), vidjeti dijelove 4.4 i 4.5.
In an independent published study, Oxycodone Cmax  1.7-fold Oxycodone AUC0-  3.6-fold
Oksikodon Cmax  1,7-puta Oksikodon AUC0-∞  3,6-puta
Kύπρος
Doziranje
Please refer to Patient Information Leaflet for detailed instructions.
Za detaljne upute pročitajte uputu o lijeku.
8, drug reaction with eosinophilia and systemic symptoms (DRESS) angioedema, actinic keratosis*, pseudoporphyria , erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus*, ephelides*, lentigo*
Johnsonov sindrom fototoksičnost, purpura, urtikarija, alergijski dermatitis, papularni osip, makularni osip, ekcem toksična epidermalna nekroliza reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS) angio edem, aktinička keratoza*, multiformni pseudoporfirijsk i eritem, psorijaza, reakcija na koži kožni lupus eritematodes *, pjege*, lentigo*
Reduction in the dose of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered when coadministered with voriconazole (see section 4.5).
Kada se primjenjuju istodobno s vorikonazolom, treba razmotriti smanjenje doze alfentanila, fentanila i ostalih kratkodjelujućih opijata koji imaju strukturu sličnu alfentanilu i metaboliziraju se pomoću CYP3A4 (npr. sufentanil) (vidjeti dio 4.5).
Keeping the vial upright, empty contents of the syringe into the vial.
Držeći bočicu uspravno, ispraznite sadržaj štrcaljke u bočicu.
Voriconazole Cmax  69% Voriconazole AUC  78%
Vorikonazol Cmax  69% Vorikonazol AUC  78%
Inflammation of the sinuses, inflammation of the gums, chills, weakness Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot Low blood sugar, low blood potassium, low sodium in the blood Anxiety, depression, confusion, agitation, inability to sleep, hallucinations Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness Bleeding in the eye
- upala sinusa, upala desni, zimica, slabost - smanjen (uključujući i značajno smanjen) broj nekih vrsta crvenih (katkad povezano s imunitetom) i/ili bijelih krvnih stanica (katkad popraćeno temperaturom), niski broj stanica koje se nazivaju trombociti i koje pomažu u zgrušavanju krvi - nizak šećer u krvi, nizak kalij u krvi, nizak natrij u krvi - tjeskoba, depresija, smetenost, uznemirenost, nemogućnost spavanja, halucinacije - napadaji, nevoljno drhtanje ili nekontrolirani pokreti mišića, trnci ili neuobičajena osjetljivost kože, povećana napetost mišića, pospanost, omaglica - krvarenje u oku -problemi sa srčanim ritmom uključujući vrlo brze otkucaje srca, vrlo spore otkucaje srca,
A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QTc interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
Klinička ispitivanja u kojima je ispitivan QTc-interval U placebom kontroliranom, randomiziranom, ukriženom ispitivanju s jednokratnom dozom lijeka praćen je učinak lijeka na QTc-interval u zdravih ispitanika.
No pharmacokinetic data are available for patients with severe hepatic cirrhosis (Child-Pugh C) (see sections 4.2 and 4.4).
Nema podataka o farmakokinetici u bolesnika s teškom cirozom jetre (Child-Pughov stadij C).
Dose for the first 24 hours
Doza tijekom prva 24 sata
300 mg QD (coadministered with voriconazole 400 mg BID)
300 mg QD (primijenjeno istodobno s vorikonazolom u dozi od 400 mg BID)
Voriconazole Cmax  49% Voriconazole AUC  69%
Vorikonazol Cmax  49% Vorikonazol AUC  69%
• This medicinal product is for single use only and any unused solution should be discarded.
• Ovaj lijek je samo za jednokratnu uporabu.
VFEND 200 mg powder for solution for infusion:
VFEND 200 mg prašak za otopinu za infuziju:
VFEND is a single dose unpreserved sterile lyophile.
VFEND je sterilni liofilizat bez konzervansa za jednokratnu primjenu.
Voriconazole Cmax  34% Voriconazole AUC  39%
Vorikonazol Cmax  34% Vorikonazol AUC  39%
Voriconazole Cmax  4% Voriconazole AUC  32%
Vorikonazol Cmax  4% Vorikonazol AUC  32%
The spike in the vial adapter will penetrate the vial seal.
Šiljak u nastavku za bočicu probit će zaštitni zatvarač bočice.
Voriconazole Cmax  18% Voriconazole AUC  23%
Vorikonazol Cmax  18% Vorikonazol AUC  23%
Compared to efavirenz 600 mg QD, Efavirenz Cmax ↔ Efavirenz AUC  17%
Efavirenz Cmax ↔ Efavirenz AUC  17%
A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor
1 boca od 45 g odmjerna čašica (s oznakom za 23 ml), štrcaljka za usta volumena 5 ml i nastavak koji se utisne u grlo boce.
Mode of Action
Način primjene
In an independent published study, Voriconazole AUC0-  59%
Vorikonazol AUC0-∞  59%
Eye disorders visual impairment retinal haemorrhage optic nerve disorder papilloedema oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Poremećaji oka oštećenje vida krvarenje u retini poremećaj vidnog živca papiloedem okulogirična kriza, diplopija, skleritis, blefaritis atrofija vidnog živca, zamućenje rožnice
Patients 40 kg and above*
Peroralno Bolesnici tjelesne težine 40 kg i više*
Tablets Patients 40 kg and above Patients less than 40 kg
Bolesnici tjelesne težine manje od 40 kg
Voriconazole Cmax  23% Voriconazole AUC  7%
Vorikonazol Cmax  23% Vorikonazol AUC  7%
SLOWLY push down the plunger of the oral syringe.
POLAGANO pritišćite klip štrcaljke za usta.
VFEND oral suspension contains sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, nedostatkom sukraze-izomaltaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
Пфайзер Люксембург САРЛ, Клон България Тел.
Pfizer Luxembourg SARL Filialas Lietuvoje Tel.
Each tablet contains 200 mg voriconazole.
Jedna tableta sadrži 200 mg vorikonazola.
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.
Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika i obično ne bi smjeli premašiti 24 sata na temperaturi od 2°C do 8°C (u hladnjaku), osim ako priprema nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
Infusion site reaction
Sadržaj kompleta za infuziju
Open the Twist-off port.
Odvijte zatvarač s ulaznog otvora.
3b Screw the syringe onto the vial adapter.
3b Navijte štrcaljku na nastavak za bočicu.
Breathing difficulties
Oštećenje jetre
VFEND is an antifungal medicine.
VFEND je lijek za liječenje gljivičnih infekcija.
Reconstituted VFEND concentrate needs to be further diluted with sodium chloride (0.9%) infusion solution within the infusion bag before it is infused.
Pripremljeni koncentrat lijeka VFEND mora se prije infuzije dodatno razrijediti otopinom natrijevog klorida za infuziju od 9 mg/ml (0,9%).
VFEND contains sodium
VFEND sadrži natrij
Read the package leaflet before use Reconstitute and dilute before use.
Prije primjene lijek se mora rekonstituirati i razrijediti.
VFEND contains sucrose
VFEND sadrži saharozu
Batch
Boca