natgillin/translations-raw huggingface dataset:
What Voriconazole Accord is and what it is used for What you need to know before you take Voriconazole Accord How to take Voriconazole Accord Possible side effects
Što je Voriconazole Accord i za što se koristi Što morate znati prije nego počnete uzimati Voriconazole Accord Kako uzimati Voriconazole Accord Moguće nuspojave
Scedosporium and Fusarium infections
Infekcije uzročnicima Scedosporium i Fusarium
• Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as Voriconazole
• nenukleozidne inhibitore reverzne transkriptaze (npr. efavirenz, delavirdin, nevirapin) (koriste se za liječenje HIV-a) (neke doze efavizina se NE SMIJU uzimati istovremeno s lijekom
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 (inter-quartile range 2027 to 6302 ng/ml), respectively.
U 10 ispitivanja s terapijskom primjenom lijeka medijan prosječnih plazmatskih koncentracija u pojedinačnih ispitanika u svim ispitivanjima bio je 2425 ng/ml (interkvartilni raspon od 1193 do 4380 ng/ml), dok je medijan maksimalnih plazmatskih koncentracija iznosio 3742 ng/ml (interkvartilni raspon od 2027 do 6302 ng/ml).
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.
Sigurnosni profil vorikonazola u odraslih temelji se na objedinjoj bazi podataka o sigurnosti primjene u više od 2000 ispitanika (uključujući 1603 odrasla bolesnika u terapijskim kliničkim ispitivanjima) i dodatnih 270 odraslih ispitanika u ispitivanjima profilakse.
In children experiencing photoaging injuries such as lentigines or ephelides, sun avoidance and dermatologic follow-up are recommended even after treatment discontinuation.
U djece s lezijama uzrokovanim fotostarenjem, kao što su lentigo ili pjege, preporučuje se izbjegavanje sunca i dermatološki kontrolni pregledi čak i nakon prekida liječenja.
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).
Podaci o sigurnosti vorikonazola u bolesnika s abnormalnim testovima funkcije jetre (aspartat transaminaza [AST], alanin transaminaza [ALT], alkalna fosfataza [AP] ili ukupan bilirubin > 5 puta od gornje granice normalne vrijednosti) su ograničeni.
The 84-day survival rate for voriconazole was statistically significantly higher than that for the comparator and a clinically and statistically significant benefit was shown in favour of voriconazole for both time to death and time to discontinuation due to toxicity.
Udio 84-dnevnog preživljenja je kod primjene vorikonazola bio statistički značajno veći od onog kod primjene usporednog lijeka, a pokazala se i klinički i statistički značajna prednost vorikonazola s obzirom na vrijeme do nastupa smrti i vrijeme do prekida terapije zbog toksičnih učinaka lijeka.
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.
U ispitivanje je bilo uključeno 55 bolesnika s teškim refraktornim sistemskim infekcijama čiji je uzročnik bila Candida (uključujući kandidemiju, diseminiranu i druge oblike invazivne kandidijaze), u kojih prethodno liječenje drugim antimikoticima, posebice flukonazolom, nije bilo djelotvorno.
How to store Voriconazole Accord Content of the pack and other information
Kako čuvati Voriconazole Accord Sadržaj pakiranja i druge informacije
The medicines in the following list must not be taken during your course of Voriconazole Accord treatment:
Lijekovi navedeni u sljedećem popisu ne smiju se uzimati za vrijeme liječenja lijekom Voriconazole Accord:
Statins (e.g., lovastatin)
Statini (npr. lovastatin)
Fentanyl AUC0-∞  1.34-fold
Fentanil AUC0-  1,34 puta
No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥65 years) and healthy young females (18-45 years).
Nisu zabilježene značajne razlike u Cmax i AUCτ između zdravih starijih žena (≥ 65 godina) i zdravih mladih žena (18-45 godina).
Voriconazole Accord must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Voriconazole Accord se ne smije primjenjivati u trudnoći, osim ako korist liječenja za majku jasno ne nadilazi mogući rizik za plod.
Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects.
Istodobna primjena peroralnog vorikonazola i peroralnog flukonazola dovela je do značajnog povećanja vrijednosti Cmax i AUCτ vorikonazola u zdravih ispitanika.
Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park, Paola, PLA 3000
KW20A Kordin Industrial Park, Paola, PLA 3000
Infections and infestations sinusitis pseudomembranou s colitis
Infekcije i infestacije sinusitis pseudomembransk i kolitis
If the liver function tests become markedly elevated, Voriconazole Accord should be discontinued, unless the medical judgment of the risk-benefit of the treatment for the patient justifies continued use.
Ako testovi funkcije jetre postanu značajno povišeni, mora se prekinuti uzimanje lijeka Voriconazole Accord, osim ako medicinska procjena rizika i koristi liječenja za bolesnika opravdava nastavak korištenja.
Interaction Geometric mean changes
Promjene geometrijske sredine
Other significant side effects whose frequency is not known, but should be reported to your doctor immediately: Skin cancer Inflammation of the tissue surrounding the bone - Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Druge značajne nuspojave čija učestalost nije poznata, ali moraju se odmah prijaviti Vašem liječniku: - rak kože - upala tkiva oko kosti - crvene, ljuskaste mrlje ili prstenasta oštećenja na koži koji mogu biti simptomi autoimune bolesti zvane kožni eritemski lupus
There are no adequate data on the use of voriconazole in pregnant women available.
Nema odgovarajućih podataka o primjeni vorikonazola u trudnica.
In an animal study, no impairment of fertility was demonstrated in male and female rats (see section 5.3).
U istraživanjima na životinjama nisu zabilježeni štetni učinci na plodnost mužjaka i ženki štakora (vidjeti dio 5.3).
Maintenance dose (after first 24 hours)
Doza održavanja (nakon prva 24 sata)
Voriconazole should be dosed as children as these young adolescents may metabolize voriconazole more similarly to children than to adults.
Vorikonazol se treba dozirati kao kod djece jer mlađi adolescenti mogu metabolizirati vorikonazol sličnije djeci nego odraslima.
Oral bioavailability may, however, be limited in paediatric patients with malabsorption and very low body weight for their age.
Međutim, bioraspoloživost nakon peroralne primjene može biti ograničena u pedijatrijskih bolesnika s lošom apsorpcijom i vrlo malom tjelesnom težinom za njihovu dob.
All other adolescents (12 to 14 years and ≥50 kg; 15 to 17 years regardless of body weight)
Svi ostali adolescenti (12 do 14 godina i ≥ 50 kg; 15 do 17 godina neovisno o tjelesnoj težini)
Reminds HCPs to provide a Patient Alert Card to the patient.
- Podsjeća zdravstvene radnike da daju bolesniku karticu s upozorenjima za bolesnika.
Fifty-three paediatric patients aged 2 to <18 years were treated with voriconazole in two prospective, open-label, non-comparative, multi-center clinical trials.
Vorikonazolom je liječeno 53 pedijatrijskih bolesnika u dobi od 2 do <18 godina u dva prospektivna, otvorena, nekomparativna, multicentrična klinička ispitivanja.
A satisfactory global response (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazoletreated patients compared to 31% of patients treated with comparator.
Zadovoljavajući opći odgovor (potpuno ili djelomično povlačenje svih simptoma bolesti kao i rendgenskih/bronhoskopskih promjena prisutnih na početku liječenja) uočen je u 53% bolesnika liječenih vorikonazolom u usporedbi s 31% bolesnika liječenih usporednim lijekom.
The efficacy and survival benefit of voriconazole versus conventional amphotericin B in the primary treatment of acute invasive aspergillosis was demonstrated in an open, randomised, multicentre study in 277immunocompromised patients treated for 12 weeks.
Prednost vorikonazola s obzirom na djelotvornost i preživljenje, u odnosu na konvencionalni amfotericin B, u primarnom liječenju akutne invazivne aspergiloze dokazana je u otvorenom, randomiziranom, multicentričnom ispitivanju s 277 imunokompromitiranih bolesnika liječenih tijekom 12 tjedana.
Benzodiazepines (e.g., midazolam, triazolam, alprazolam)
Benzodiazepini (npr. midazolam, triazolam, alprazolam)
Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir)*
Drugi inhibitori HIV proteaze (npr. sakvinavir, amprenavir i nelfinavir)*
If Voriconazole Accord is continued, however, dermatologic evaluation should be performed on a systematic and regular basis, to allow early detection and management of premalignant lesions.
Ako se, usprkos tome, nastavlja primjena lijeka Voriconazole Accord, dermatološku procjenu treba provoditi sistematično i redovito, kako bi se omogućila rana detekcija i liječenje premalignih lezija.
Ranitidine (150 mg BID)
Ranitidin (150 mg BID)
As Voriconazole Accord has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidney by doing blood tests.
S obzirom da je poznato da Voriconazole Accord utječe na jetru i bubrege, liječnik Vam mora pratiti funkciju jetre i bubrega putem krvnih pretraga.
It is recommended that all patients, including children, avoid exposure to direct sunlight during Voriconazole Accord treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Preporučuje se da svi bolesnici tijekom primjene lijeka Voriconazole Accord, uključujući djecu, izbjegavaju izlaganje izravnoj sunčevoj svjetlosti te koriste zaštitnu odjeću i sredstva za zaštitu od sunca s visokim zaštitnim faktorom (SPF).
Monitoring of hepatic function should be carried out in both children and adults.
Praćenje funkcije jetre potrebno je obavljati u djece i u odraslih.
• The other ingredients are lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone and magnesium stearate which make up the tablet core and hypromellose, titanium dioxide (E171), lactose monohydrate and triacetin which make up the film-coat.
• Drugi sastojci su: laktoza hidrat, prethodno geliran škrob, umrežena karmelozanatrij, povidon i magnezijev stearat koji čine jezgru tablete te hipromeloza, titanijev dioksid (E171), laktoza hidrat i triacetin koji čine film ovojnicu.
including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
Aspergillus uključujući A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, vrste iz roda Candida uključujući C. albicans, C. glabrata, C. krusei, C.parapsilosis i C. tropicalis i za ograničen broj C. dubliniensis, C. inconspicua i C. guilliermondii, vrste iz roda Scedosporium uključujući S. apiospermum, S. prolificans te vrste iz roda Fusarium.
After an oral single-dose (200 mg), AUC was 233 % higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function.
Nakon primjene jedne peroralne doze (200 mg) AUC je bio 233% veći u ispitanika s blagom do umjereno teškom cirozom jetre (Child-Pughov stadij A i B) u usporedbi s ispitanicima s normalnom jetrenom funkcijom.
Reminds HCPs of use of the HCP Checklist and the Patient Alert Card and how to obtain additional copies.
- Podsjeća zdravstvene radnike na korištenje kontrolnog popisa i kartice s upozorenjima za bolesnika te kako dobiti dodatne primjerke.
Nine subjects in the voriconazole group and 5 in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
Devet bolesnika iz skupine liječene vorikonazolom i 5 iz skupine liječene amfotericinom B pa potom flukonazolom, imali su i mikološki dokazanu infekciju dubokih tkiva.
A comparison of the paediatric and adult population pharmacokinetic data indicated that the predicted total exposure (AUCτ) in children following administration of a 9 mg/kg IV loading dose was comparable to that in adults following a 6 mg/kg IV loading dose.
Usporedba farmakokinetičkih podataka u pedijatrijskoj i odrasloj populaciji pokazala je da je predviđena ukupna izloženost (AUCτ ) u djece nakon intravenske primjene udarne doze od 9 mg/kg bila usporediva s onom u odraslih nakon intravenske primjene udarne doze od 6 mg/kg.
If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking Voriconazole Accord.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja lijeka Voriconazole Accord.
Efavirenz (a non-nucleoside reverse transcriptase inhibitor)
Efavirenz (nenukleozidni inhibitor reverzne transkriptaze)
Reminds HCPs to discuss with the patient/care giver the risks of phototoxicity/skin SCC and hepatotoxicity, what to look for, how and when to seek immediate attention.
- Podsjeća zdravstvene radnike da razgovaraju s bolesnikom/skrbnikom o riziku od fototoksičnosti/SCC-a i toksičnosti za jetru, što tražiti, kako i kada potražiti hitnu pomoć.
Other medicines and Voriconazole Accord
Drugi lijekovi i Voriconazole Accord
Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome.
Još su 4 bolesnika s fuzariozom imala infekciju izazvanu više nego jednim uzročnikom, a u dvoje od njih je ishod liječenja bio pozitivan.
12 weeks after EOT 104 (42%)
12 tjedana po završetku liječenja 104 (42%)
The overall incidence of transaminase increases>3xULN (not necessarily comprising an adverse event) in the voriconazole clinical programme was 18.0% (319/1,768) in adults and 25.8% (73/283) in paediatric subjects who received voriconazole for pooled therapeutic and prophylaxis use.
Ukupna incidencija povećanja vrijednosti transaminaza >3 x ULN (ne nužno uključujući i nuspojavu) u ispitanika koji su u kliničkim ispitivanjima primali vorikonazol iznosila je 18,0 % (319/1768) u odraslih i 25,8 % (73/238) kod pedijatrijskih ispitanika koji su primili vorikonazol u kombiniranu terapeutsko-profilaktičku svrhu.
Clinical efficacy defined as partial or complete response, has been demonstrated for Aspergillus spp.
Klinička je djelotvornost, definirana kao djelomičan ili potpun odgovor, dokazana za vrste iz roda
Carbamazepine and longacting barbiturates (e.g., phenobarbital, mephobarbital)
Karbamazepin i barbiturati dugog djelovanja (npr. fenobarbital, mefobarbital)
S-Ibuprofen Cmax  20% S-Ibuprofen AUC0-∞  100% Diclofenac Cmax  114% Diclofenac AUC0-∞  78%
S-ibuprofen Cmax  20% S-ibuprofen AUC0-  100% Diklofenak Cmax  114% Diklofenak AUC0-  78%
There have been reports of squamous cell carcinoma of the skin in patients treated with Voriconazole Accord for long periods of time; the mechanism has not been established (see section 4.4).
Prijavljen je karcinom skvamoznih stanica na koži u bolesnika koji su liječeni Voriconazole Accordom kroz duži vremenski period, mehanizam djelovanja još nije utvrđen (vidjeti dio 4.4).
6 weeks after EOT 104 (42%)
6 tjedana po završetku liječenja 104 (42%)
Macrolide antibiotics Erythromycin (1 g BID)
Makrolidni antibiotici Eritromicin (1 g BID) [inhibitor
Musculoskele tal and connective tissue disorders back pain arthritis periostitis*
Poremećaji mišićnokoštanog sustava i vezivnog tkiva bol u leđima artritis periostitis*
Non-Steroidal AntiInflammatory Drugs (NSAIDs)
Nesteroidni protuupalni lijekovi (NSAR)
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.
Kožne su reakcije bile vrlo česte u bolesnika liječenih vorikonazolom u kliničkim ispitivanjima, no to su bili bolesnici s teškim osnovnim bolestima koji su istodobno primali velik broj lijekova.
Patients receiving Voriconazole Accord must be carefully monitored for hepatic toxicity.
U bolesnika koji uzimaju Voriconazole Accord mora se pažljivo pratiti hepatotoksičnost.
Caution should be used in prescribing Voriconazole Accord to patients with hypersensitivity to other azoles (see also section 4.8).
Potreban je oprez kod propisivanja lijeka Voriconazole Accord bolesnicima preosjetljivima na ostale azole (vidjeti i dio 4.8).
Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or Voriconazole Accord are still having the desired effect:
Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova, jer će možda trebati prilagoditi dozu lijeka ili provjeravati imaju li oni i/ili Voriconazole Accord i dalje željeni učinak:
What you need to know before you take Voriconazole Accord
Što morate znati prije nego počnete uzimati Voriconazole Accord
There is a small chance that skin cancer could develop with long-term use of Voriconazole Accord.
Postoji mala šansa od razvoja karcinoma kože uz dugoročnu primjenu lijeka Voriconazole Accord.
The predicted total exposure in children following an oral maintenance dose of 9 mg/kg (maximum of 350 mg) twice daily was comparable to that in adults following 200 mg oral twice daily.
Predviđena ukupna izloženost u djece nakon primjene peroralne doze održavanja od 9 mg/kg (najviše 350 mg) dvaput na dan bila je usporediva s onom u odraslih nakon primjene doze od 200 mg dvaput na dan.
R-methadone (active) Cmax  R-methadone (active) AUCτ  S-methadone Cmax  65% S-methadone AUCτ  103%
R-metadon (aktivni) Cmax  31% R-metadon (aktivni) AUC  47% S-metadon Cmax  65% S-metadon AUC  103%
Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Liječenje teških invazivnih infekcija uzrokovanih kandidom (uključujući C. krusei) rezistentnih na flukonazol.
Side effects with frequency not known: - Freckles and pigmented spots
Nuspojave s nepoznatom učestalošću: - pjege i pigmentirane mrlje
Cimetidine (400 mg BID)
Cimetidin (400 mg BID)
In an oral single dose (200 mg) study in subjects with normal renal function and mild (creatinine clearance 41-60 ml/min) to severe (creatinine clearance < 20ml/min) renal impairment, the pharmacokinetics of voriconazole were not significantly affected by renal impairment.
U ispitivanju primjene jedne peroralne doze (200 mg) u ispitanika s normalnom bubrežnom funkcijom i blagim (klirens kreatinina 41-60 ml/min) do teškim oštećenjem bubrega (klirens kreatinina < 20 ml/min), utvrđeno je da oštećenje bubrežne funkcije nema značajnijeg utjecaja na farmakokinetiku vorikonazola.
As the half-life of alfentanil is prolonged in a 4-fold manner when alfentanil is coadministered with voriconazole, and in an independent published study concomitant use of voriconazole with fentanyl resulted in an increase in the mean AUC0-∞ of fentanyl, frequent monitoring for opiate-associated adverse reactions (including a longer respiratory monitoring period) may be necessary.
Budući da je poluvijek alfentanila četverostruko produljen pri istodobnoj primjeni alfentanila s vorikonazolom, a u neovisnom je objavljenom ispitivanju istodobna primjena vorikonazola s fentanilom rezultirala povećanjem prosječnog AUC0-∞ fentanila, možda će biti potrebne česte kontrole zbog mogućih nuspojava povezanih s opijatima (uključujući dulji nadzor respiratorne funkcije).
Voriconazole Accord should be administered primarily to patients with progressive, possibly lifethreatening infections.
Voriconazole Accord treba primjenjivati prvenstveno u bolesnika s progresivnim, možda i po život opasnim infekcijama.
• Alfentanil and fentanyl and other short-acting opiates such as sufentanil (painkillers used for surgical procedures)
• alfentanil, fentanil i ostale opijate kratkog djelovanja, kao što je sufentanil (lijekovi protiv bolova koji se koriste kod kirurških zahvata)
Completed at least 100 days of study drug prophylaxis Survived to day 180
Dovršeno najmanje 100 dana profilakse ispitivanim lijekom
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Blister foil for 50 mg film-coated tablets (all blister packs))
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister (Blister folija za 50 mg filmom obložene tablete (sva blister pakiranja))
• serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),
• teške invazivne infekcije uzrokovane vrstama iz roda Candida kada je gljivica otporna na flukonazol (drugi antifungalni lijek),
During oral administration of 200 mg or 300 mg twice daily for 14 days in patients at risk of aspergillosis (mainly patients with malignant neoplasms of lymphatic or haematopoietic tissue), the observed pharmacokinetic characteristics of rapid and consistent absorption, accumulation and nonlinear pharmacokinetics were in agreement with those observed in healthy subjects.
Tijekom 14-dnevne peroralne primjene vorikonazola u dozi od 200-300 mg dvaput na dan u bolesnika s rizikom za razvoj aspergiloze (uglavnom bolesnika s malignim neoplazmama limfatičkog i hematopoetskog sustava) opažena farmakokinetička svojstva - brza i stabilna apsorpcija, kumulacija i nelinearna farmakokinetika - odgovarala su onima opaženima u zdravih ispitanika.
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used for treating pain and
• nesteroidne protuupalne lijekove (npr. ibuprofen, diklofenak) (koriste se za liječenje boli i
Take your box of Voriconazole Accord tablets with you.
Ponesite sa sobom kutiju lijeka Voriconazole Accord.
2 film-coated tablets 10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 100 film-coated tablets 10x1 film-coated tablets 14x1 film-coated tablets 28x1 film-coated tablets 30x1 film-coated tablets 56x1 film-coated tablets 100x1 film-coated tablets
2 filmom obložene tablete 10 filmom obloženih tableta 14 filmom obloženih tableta 20 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 100 filmom obloženih tableta 10x1 filmom obložena tableta 14x1 filmom obložena tableta 28x1 filmom obložena tableta 30x1 filmom obložena tableta 56x1 filmom obložena tableta 100x1 filmom obložena tableta
The effect of voriconazole on either erythromycin or azithromycin is unknown
↔ Nije poznat učinak vorikonazola ni na eritromicin ni na azitromicin.
Multiple intravenous doses of 3, 4, 6, 7 and 8 mg/kg twice daily and multiple oral doses (using the powder for oral suspension) of 4 mg/kg, 6 mg/kg, and 200 mg twice daily were evaluated in 3 paediatric pharmacokinetic studies.
Primjena višekratnih intravenskih doza od 3, 4, 6, 7 i 8 mg/kg dvaput na dan te višekratnih peroralnih doza (koristeći prašak za oralnu suspeziju) od 4 mg/kg i 6 mg/kg te 200 mg dvaput na dan ocijenjena je u 3 pedijatrijska farmakokinetička ispitivanja.
PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets or unit dose PVC / Aluminium blister in pack sizes of 10x1, 14x1, 28x1, 30x1, 56x1 or 100x1 film-coated tablets.
PVC/aluminijski blisteri u kutijama sa 2, 10, 14, 20, 28, 30, 50, 56 ili 100 filmom obloženih tableta ili PVC/aluminijski blisteri s jediničnim dozama, u kutijama sa 10x1, 14x1, 28x1, 30x1, 56x1 ili 100x1 filmom obloženom tabletom.