natgillin/translations-raw huggingface dataset:
In clinical studies, response to voriconazole in patients with C. glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
U kliničkim ispitivanjima je odgovor na vorikonazol u bolesnika s infekcijama uzročnika C. glabrata bio 21% niži u odnosu na one infekcije čiji su uzročnici bili C. albicans, C. parapsilosis i C. tropicalis.
Voriconazole Cmax and AUC ↔
Vorikonazol Cmax i AUC
• For dilution, gently invert the vial, vial adapter and syringe assembly and withdraw the required volume of the reconstituted concentrate into the syringe (see table below).
• Za razrjeđivanje, nježno preokrenite sklop bočice, nastavka za bočicu i štrcaljke te izvucite potreban volumen rekonstituiranog koncentrata u štrcaljku (vidjeti sljedeću tablicu).
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 peroralne primjene doze od 200 mg dvaput na dan.
Coadministration of standard doses of voriconazole with efavirenz doses of 400 mg once daily or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses.
Istodobna primjena standardne doze vorikonazola s dozama efavirenza od 400 mg jedanput na dan ili više je kontraindicirana, jer efavirenz u toj dozi značajno smanjuje koncentraciju vorikonazola u plazmi zdravih ispitanika.
- 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.
Careful monitoring for any occurrence of drug toxicity and/or lack of efficacy, and dose adjustment may be needed.
Možda će biti potrebno pomno pratiti bolesnika zbog moguće toksičnosti i/ili nedostatka djelotvornosti lijeka te eventualno prilagoditi dozu.
Each bottle contains 3 g of voriconazole.
Jedna bočica sadrži 3 g vorikonazola.
VFEND 200 mg film-coated tablets Each tablet contains 253.675 mg lactose monohydrate.
VFEND 200 mg filmom obložene tablete Jedna tableta sadrži 253,675 mg laktoze hidrata.
• Once the syringe is reconnected to the blue port of the infusion bag, the contents are then emptied into the infusion bag from the syringe to provide a final voriconazole solution containing 0.5-5 mg/ml.
• Nakon je štrcaljka ponovno priključena na plavi ulazni otvor infuzijske vrećice, sadržaj se zatim prazni u infuzijsku vrećicu iz štrcaljke kako bi se dobila konačna otopina vorikonazola koja sadrži 0,5 - 5 mg/ml.
All occurred in paediatric patients, who received up to five times the recommended intravenous dose of voriconazole.
Sva 3 slučaja zabilježena su u pedijatrijskih bolesnika koji su dobili do 5 puta veću intravensku dozu vorikonazola od preporučene.
When the recommended intravenous or oral loading dose regimens are administered, plasma concentrations close to steady state are achieved within the first 24 hours of dosing.
Kada se primjenjuju preporučene intravenske ili peroralne udarne doze, koncentracije lijeka u plazmi približne vrijednostima u stanju dinamičke ravnoteže postižu se već tijekom prva 24 sata nakon primjene.
Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended.
Preporučuju se česte kontrole zbog mogućih nuspojava i toksičnosti povezane s NSAILom.
Rifabutin Cmax  195% Rifabutin AUC  331% Compared to voriconazole 200 mg BID,
Rifabutin Cmax  195% Rifabutin AUC  331% U usporedbi s dozom vorikonazola od 200 mg BID,
Bioequivalence was established between the 200 mg tablet and the 40 mg/ml oral suspension when administered as a 200 mg dose.
Utvrđena je bioekvivalencija između tablete od 200 mg i oralne suspenzije od 40 mg/ml kada je suspenzija primijenjena kao doza od 200 mg.
Ibuprofen (400 mg single dose)
Ibuprofen (jedna doza od 400 mg)
Excipient with known effect Each ml of suspension contains 0.54 g sucrose.
Pomoćna tvar s poznatim učinkom Jedan ml suspenzije sadrži 0,54 g saharoze.
In a secondary analysis, which utilised DRC assessments at the latest evaluable time point (EOT, or 2, 6, or 12 weeks after EOT) voriconazole and the regimen of amphotericin B followed by fluconazole had successful response rates of 65% and 71%, respectively.
U sekundarnoj analizi u kojoj su korištene ocjene DRC-a u posljednjoj ocjenjivoj vremenskoj točki (završetak liječenja, odnosno 2, 6 ili 12 tjedana po završetku liječenja), stopa pozitivnog odgovora u skupini liječenoj vorikonazolom iznosila je 65%, a u skupini liječenoj amfotericinom B pa potom flukonazolom 71%.
Breast-feeding must be stopped on initiation of treatment with VFEND.
Dojenje se mora prekinuti prije početka liječenja lijekom VFEND.
Voriconazole was administered intravenously with a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours for a minimum of 7 days.
Vorikonazol se primjenjivao intravenski, počevši s udarnom dozom od 6 mg/kg svakih 12 sati tijekom prva 24 sata i nastavljajući dozom održavanja od 4 mg/kg svakih 12 sati tijekom najmanje 7 dana.
The plasma protein binding of voriconazole was similar in subjects with different degrees of renal impairment (see sections 4.2 and 4.4).
Vezivanje vorikonazola za proteine plazme bilo je podjednako u ispitanika s različitim stupnjevima bubrežnog oštećenja (vidjeti dijelove 4.2 i 4.4).
It is likely that these subjects may metabolize voriconazole more similarly to children than to adults.
Ti ispitanici vjerojatno mogu metabolizirati vorikonazol sličnije djeci nego odraslima.
Rare: may affect up to 1 in 1000 people
Rijetke: mogu se javiti u do 1 na 1000 osoba
1 sterile, single use, foil overwrapped, polypropylene bag containing VFEND solvent for solution for infusion in one compartment (50 ml).
1 sterilnu polipropilensku vrećicu za jednokratnu uporabu, omotanu u foliju, koja sadrži VFEND otapalo za otopinu za infuziju u jednom odjeljku (50 ml).
After IV voriconazole therapy, the median duration of oral voriconazole therapy was 76 days (range 2-232 days).
Nakon intravenskog je liječenja medijan trajanja peroralne primjene vorikonazola iznosio 76 dana (raspon 2-232 dana).
including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp.
P.marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis i vrstama iz roda Trichosporon, uključujući T. beigelii.
Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
liječenje ozbiljnih invazivnih infekcija uzrokovanih kandidom (uključujući C. krusei) rezistentnih na flukonazol.
Therefore, from a microbiological point of view, the reconstituted solution must be used immediately.
Stoga se, s mikrobiološkog stanovišta, jednom rekonstituirana otopina mora odmah primijeniti.
Fentanyl (5 g/kg single dose)
Fentanil (jedna doza od 5 g/kg)
Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Na temelju populacijske farmakokinetičke analize u 112 imunokompromitiranih pedijatrijskih bolesnika u dobi od 2 do < 12 godina te 26 imunokompromitiranih adolescenata u dobi od 12 do < 17 godina.
• 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 za vrijeme kirurških zahvata)
Solvent for solution for infusion:
Otapalo za otopinu za infuziju:
Side effects with frequency not known: Freckles and pigmented spots
Nuspojave s nepoznatom učestalošću: - pjege i pigmentirane mrlje
Film-coating Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate
Film ovojnica: hipromeloza titanijev dioksid (E171) laktoza hidrat gliceroltriacetat
If this occurs, turn the vial upright and pull the piston up the syringe barrel.
Ako se to dogodi, okrenite bočicu uspravno i povucite klip štrcaljke prema gore.
Duration of treatment The duration of treatment with the intravenous formulation should be no longer than 6 months (see section
Trajanje liječenja Liječenje intravenskim oblikom lijeka ne smije trajati dulje od 6 mjeseci (vidjeti dio 5.3).
• tell your doctor immediately if you develop o sunburn o severe skin rash or blisters o bone pain
• odmah recite svom liječniku ako dobijete o opekline od sunca o teški osip ili mjehure na koži o osjetite bol u kostima
• serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),
• ozbiljne invazivne infekcije uzrokovane vrstama iz roda Candida kada je gljivica otporna na flukonazol (drugi lijek za liječenje gljivičnih infekcija),
Put the tip of the oral syringe into the mouth.
Stavite vrh štrcaljke u usta.
Any remaining suspension should be discarded 14 days after constitution.
Sva preostala suspenzija treba se zbrinuti 14 dana nakon pripreme.
Careful monitoring of full blood counts and adverse reactions to rifabutin (e.g., uveitis) is recommended when rifabutin is coadministered with voriconazole.
Preporučuje se pažljivo praćenje kompletne krvne slike i nuspojava rifabutina (npr. uveitisa) kada ga se primjenjuje istodobno s vorikonazolom.
Snap open the blue port of the infusion bag.
Otvorite plavi ulazni otvor na infuzijskoj vrećici.
In patients with moderate to severe renal dysfunction (serum creatinine levels > 2.5 mg/dl), accumulation of the intravenous vehicle, SBECD, occurs (see sections 4.2 and 4.4).
U bolesnika s umjerenom do teškom disfunkcijom bubrega (razine kreatinina u serumu > 2,5 mg/dl) dolazi do kumulacije intravenskog vehikuluma SBECD-a (vidjeti dijelove 4.2 i 4.4).
VFEND is intended for patients with worsening, possibly life-threatening, fungal infections.
VFEND je namijenjen bolesnicima s gljivičnim infekcijama koje se pogoršavaju, a mogu biti opasne po život.
This represents a heterogeneous population, containing patients with haematological malignancy, HIV-infected patients with oesophageal candidiasis and refractory fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
Riječ je o heterogenoj populaciji sastavljenoj od bolesnika s malignim hematološkim bolestima, bolesnika s kandidijazom jednjaka i refraktornim gljivičnim infekcijama zaraženih virusom HIV-a, bolesnika bez neutropenije s kandidemijom ili aspergilozom te zdravih dobrovoljaca.
Powder for oral suspension: store at 2°C - 8°C (in a refrigerator) before constitution.
Prašak za oralnu suspenziju: prije pripreme čuvati na temperaturi od 2°C do 8°C (u hladnjaku).
Not for use with other products
Ne smije se koristiti s drugim lijekovima.
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 malom apsorpcijom i vrlo malom tjelesnom težinom za njihovu dob.
Coadministration of voriconazole and low-dose ritonavir (100 mg BID) should be avoided unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Istodobnu primjenu vorikonazola i niske doze ritonavira (100 mg BID) treba izbjegavati, osim kad procjena odnosa koristi i rizika za bolesnika opravdava primjenu vorikonazola.
In the table below, since the majority of the studies were of an open nature, all causality adverse reactions and their frequency categories in 1,873 adults from pooled therapeutic (1,603) and prophylaxis (270) studies, by system organ class, are listed.
S obzirom da je većina ispitivanja bila otvorenog tipa, u sljedećoj su tablici navedene nuspojave svih uzroka i kategorije učestalosti kod 1873 odrasle osobe iz kombiniranih terapeutskih (1603) i profilaktičkih (270) ispitivanja, razvrstane prema organskim sustavima.
In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., and Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 µg/ml.
Zabilježena je aktivnost in vitro protiv kliničkih izolata vrsta iz rodova Acremonium, Alternaria, Bipolaris i Cladophialophora te Histoplasma capsulatum, gdje je najveći broj sojeva bio inhibiran pri koncentracijama vorikonazola u rasponu od 0,05 do 2 µg/ml.
These oral dose recommendations for children are based on studies in which voriconazole was administered as the powder for oral suspension.
Preporuke za peroralno doziranje vorikonazola u djece temelje se na ispitivanjima u kojima se vorikonazol primjenjivao u obliku praška za oralnu suspenziju.
Slowly draw off the required volume of the solution.
Polako navucite potreban volumen otopine.
Phenytoin (CYP2C9 substrate and potent CYP450 inducer) Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Fenitoin (supstrat CYP2C9 i snažan induktor CYP450) Preporučuje se pažljivo praćenje koncentracije fenitoina kada ga se primjenjuje istodobno s vorikonazolom.
This includes cases of jaundice, hepatitis and hepatic failure leading to death (see section 4.4).
Tu se ubrajaju slučajevi žutice, hepatitisa i zatajenja jetre sa smrtnim ishodom (vidjeti dio 4.4).
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 non-linear pharmacokinetics were in agreement with those observed in healthy subjects.
Tijekom 14-dnevne peroralne primjene vorikonazola u dozi od 200 mg ili 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.
Voriconazole is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine.
Vorikonazol se eliminira putem jetrenog metabolizma, a svega 2% doze izlučuje se mokraćom u nepromijenjenom obliku.
The compatibility of VFEND with diluents other than listed above (or listed below under ‘Incompatibilities') is unknown.
Nije poznata kompatibilnost lijeka VFEND s drugim otopinama za razrjeđivanje, osim prethodno navedenih (ili onih navedenih u dijelu "Inkompatibilnosti").
Coadministration with high-dose ritonavir (400 mg and above twice daily) because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this dose (see section 4.5, for lower doses see section 4.4).
Istodobna primjena s visokom dozom ritonavira (400 mg i više dvaput na dan), jer ritonavir u toj dozi značajno smanjuje koncentraciju vorikonazola u plazmi zdravih ispitanika (vidjeti dio 4.5; za manje doze vidjeti dio 4.4).
Rifampicin (600 mg QD) [potent CYP450 inducer]
Rifampicin (600 mg QD) [snažan induktor CYP450]
Replace the cap and shake the bottle vigorously for about 1 minute.
Vratite zatvarač i snažno tresite bocu otprilike 1 minutu.
Voriconazole should be administered with caution in patients with concomitant medication that is known to prolong QTc interval.
Vorikonazol treba primjenjivati s oprezom u bolesnika koji istodobno primaju lijekove koji produljuju QTc-interval.
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
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
VFEND 50 mg film-coated tablets Each tablet contains 63.42 mg lactose monohydrate.
VFEND 50 mg filmom obložene tablete Jedna tableta sadrži 63,42 mg laktoze hidrata.
In case of use as prophylaxis, refer below.
U slučaju upotrebe kao profilakse, pogledajte u nastavku.
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.
Tacrolimus Cmax  117% Tacrolimus AUCt  221%
Takrolimus Cmax  117% Takrolimus AUCt  221%
Sirolimus (2 mg single dose)
Sirolimus (jedna doza od 2 mg)
A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8).
Kod pedijatrijske populacije primijećena je veća učestalost povišenih enzima jetre (vidjeti dio 4.8).
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Uvjete čuvanja nakon pripremanja lijeka za primjenu vidjeti u dijelu 6.3.
HDPE tablet containers containing 2, 30 or 100 film-coated tablets.
Spremnici za tablete od polietilena visoke gustoće (HDPE) koji sadrže 2, 30 ili 100 filmom obloženih tableta.
Each bottle contains 45 g of powder providing 70 ml of suspension when constituted with water as recommended.
Jedna boca sadrži 45 g praška, iz kojeg se nakon pripreme s vodom prema uputama dobiva 70 ml suspenzije.
Point the tip of the oral syringe towards the inside of the cheek.
Usmjerite vrh štrcaljke za usta na unutarnju stranu obraza.
• The VFEND solvent for solution for infusion is then added to the vial by unscrewing the syringe from the bag, connecting it to the vial adapter and then emptying the contents from the syringe into the vial.
• Zatim se VFEND otapalo za otopinu za infuziju dodaje u bočicu tako što se odvije štrcaljka s vrećice, priključujući je na nastavak za bočicu i zatim se isprazni sadržaj iz štrcaljke u bočicu.
Shake bottle for approximately 10 seconds before use.
Prije uporabe protresite bocu približno 10 sekundi.
In vitro studies show that voriconazole may inhibit the metabolism of HIV protease inhibitors and the metabolism of voriconazole may also be inhibited by HIV protease inhibitors.
Ispitivanja in vitro pokazuju da vorikonazol može inhibirati metabolizam inhibitora HIV proteaze, ali i da inhibitori HIV proteaze također mogu inhibirati metabolizam vorikonazola.
Depending on your response to treatment, your doctor may increase the daily dose to 300 mg twice a day.
Ovisno o Vašem odgovoru na liječenje, liječnik može povećati dnevnu dozu na 300 mg dva puta na dan.
VFEND 200 mg powder and solvent for solution for infusion: VFEND powder and solvent for solution for infusion is available in a box containing:
VFEND 200 mg prašak i otapalo za otopinu za infuziju: VFEND prašak i otapalo za otopinu za infuziju dostupni su u kutiji koja sadrži:
Method of administration VFEND film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
VFEND filmom obložene tablete moraju se uzimati najmanje jedan sat prije ili jedan sat nakon obroka.
Not for bolus injection.
Nije namijenjeno za bolusnu injekciju.
Considering the assumed limited gastroenteric transit time in paediatric patients, the absorption of tablets may be different in paediatric compared to adult patients.
S obzirom na pretpostavljeno kratko vrijeme prolaska kroz probavni sustav u pedijatrijskih bolesnika, moguća je i razlika u apsorpciji tableta između pedijatrijskih i odraslih bolesnika.
In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole-resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
Vorikonazol pokazuje širok spektar antifungalne aktivnosti in vitro, sa snažnim djelovanjem protiv vrsta iz roda Candida (uključujući C. krusei rezistentnu na flukonazol i rezistentne sojeve C. glabrata i C. albicans) te fungicidnim djelovanjem protiv svih ispitanih vrsta iz roda Aspergillus.
If you take more suspension than prescribed (or if someone else takes your suspension) you must seek medical advice or go to the nearest hospital casualty department immediately.
Vašu suspenziju), morate odmah zatražiti savjet liječnika ili otići u hitnu službu najbliže bolnice.
Dosage adjustments in case of co-administration Rifabutin or phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg intravenously twice daily, see sections 4.4 and 4.5.
Prilagodba doze u slučaju istodobne primjene Rifabutin ili fenitoin se smije istodobno primijeniti s vorikonazolom ako se doza održavanja vorikonazola poveća na 5 mg/kg intravenski dvaput na dan, vidjeti dijelove 4.4 i 4.5.
Each tablet contains either 50 mg voriconazole (for VFEND 50 mg film-coated tablets) or 200 mg voriconazole (for VFEND 200 mg film-coated tablets).
Jedna tableta sadrži ili 50 mg vorikonazola (VFEND 50 mg filmom obložene tablete) ili 200 mg vorikonazola (VFEND 200 mg filmom obložene tablete).
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine.
Pokazalo se da se djelotvornost Vašeg lijeka može znatno povećati ako sve doze uzimate redovito i u predviđeno vrijeme.
In an independent published study, Alfentanil AUC0-  6-fold
Alfentanil AUC0-∞  6 puta
Use of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated (see section 4.3).
Primjena standardnih doza vorikonazola s dozama efavirenza od 400 mg QD ili više je kontraindicirana (vidjeti dio 4.3).
Contraindicated (see section
Kontraindicirana (vidjeti dio 4.3)
In reproduction studies, voriconazole was shown to be teratogenic in rats and embryotoxic in rabbits at systemic exposures equal to those obtained in humans with therapeutic doses.
U ispitivanjima reproduktivne toksičnosti vorikonazol se pokazao teratogenim u štakora te embriotoksičnim u kunića, pri sustavnoj izloženosti jednakoj onoj koja se postiže u ljudi primjenom terapijskih doza.
What VFEND looks like and contents of the pack VFEND is presented in single use glass vials as a powder for solution for infusion.
Kako VFEND izgleda i sadržaj pakiranja VFEND je dostupan u obliku praška za otopinu za infuziju u staklenoj bočici za jednokratnu uporabu.
EU/1/02/212/013 2 film-coated tablets EU/1/02/212/014 10 film-coated tablets EU/1/02/212/015 14 film-coated tablets EU/1/02/212/016 20 film-coated tablets EU/1/02/212/017 28 film-coated tablets EU/1/02/212/018 30 film-coated tablets EU/1/02/212/019 50 film-coated tablets EU/1/02/212/020 56 film-coated tablets EU/1/02/212/021 100 film-coated tablets EU/1/02/212/037 2 film-coated tablets EU/1/02/212/038 10 film-coated tablets EU/1/02/212/039 14 film-coated tablets EU/1/02/212/040 20 film-coated tablets EU/1/02/212/041 28 film-coated tablets EU/1/02/212/042 30 film-coated tablets EU/1/02/212/043 50 film-coated tablets EU/1/02/212/044 56 film-coated tablets EU/1/02/212/045 100 film-coated tablets
EU/1/02/212/013 2 filmom obložene tablete EU/1/02/212/014 10 filmom obloženih tableta EU/1/02/212/015 14 filmom obloženih tableta EU/1/02/212/016 20 filmom obloženih tableta EU/1/02/212/017 28 filmom obloženih tableta EU/1/02/212/018 30 filmom obloženih tableta EU/1/02/212/019 50 filmom obloženih tableta EU/1/02/212/020 56 filmom obloženih tableta EU/1/02/212/021 100 filmom obloženih tableta EU/1/02/212/037 2 filmom obložene tablete EU/1/02/212/038 10 filmom obloženih tableta EU/1/02/212/039 14 filmom obloženih tableta EU/1/02/212/040 20 filmom obloženih tableta EU/1/02/212/041 28 filmom obloženih tableta EU/1/02/212/042 30 filmom obloženih tableta EU/1/02/212/043 50 filmom obloženih tableta EU/1/02/212/044 56 filmom obloženih tableta EU/1/02/212/045 100 filmom obloženih tableta