natgillin/translations-raw huggingface dataset:
The pharmacokinetics of posaconazole tablets are comparable in young and elderly subjects.
Farmakokinetika posakonazol tableta u mladih usporediva je s onom u starijih ispitanika.
• breast pain
• glavobolja
Do not breast-feed while using Noxafil.
Nemojte dojiti dok primjenjujete Noxafil.
Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial.
800 mg na dan podijeljena u doze kao terapija spašavanja u liječenju invazivne aspergiloze u bolesnika s bolešću otpornom na amfotericin B (uključujući liposomalne formulacije) ili itrakonazol ili u bolesnika koji nisu podnosili te lijekove.
Tablet core
Mjerna žličica
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Noxafil.
Ako se nešto od gore navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Noxafil.
• infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;
• infekcija prouzročenih gljivicama koje uzrokuju bolesti kromoblastomikozu i micetom, a koje se nisu poboljšale tijekom liječenja itrakonazolom ili kada se liječenje itrakonazolom moralo prekinuti;
Each gastro-resistant tablet contains 100 mg of posaconazole.
Jedna želučanootporna tableta sadrži 100 mg posakonazola.
Steadystate plasma concentrations are attained by Day 6 at the 300 mg dose (once daily after twice daily loading dose at Day 1).
Stanje dinamičke ravnoteže koncentracija u plazmi postiže se do 6. dana uz primjenu doze od 300 mg (jedanput na dan, nakon udarne doze primijenjene dvaput na dan 1. dana).
Loading dose of 300 mg Noxafil twice a day on the first day, then 300 mg once a day thereafter.
Udarna doza od 300 mg lijeka Noxafil dvaput na dan prvog dana, a zatim 300 mg jedanput na dan.
In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
U drugom ispitivanju u zdravih dobrovoljaca višestruka primjena doza posakonazol oralne suspenzije (200 mg dvaput na dan tijekom 7 dana) povećala je Cmax intravenski primijenjenog midazolama (u jednokratnoj dozi od 0,4 mg) za prosječno 1,3 puta, a AUC za prosječno 4,6 puta (raspon od 1,7 do 6,4 puta).
Morphine sulphate Norepinephrine bitartrate Potassium chloride Vancomycin hydrochloride
amikacinsulfat kaspofungin ciprofloksacin daptomicin dobutaminklorid famotidin filgrastim gentamicinsulfat hidromorfonklorid levofloksacin lorazepam meropenem mikafungin morfinsulfat norepinefrin bitartrat kalijev klorid vankomicinklorid
• infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;
• infekcija prouzročenih gljivicama iz roda Aspergillus koje se nisu poboljšale tijekom liječenja antimikoticima amfotericinom B ili itrakonazolom ili kada se liječenje tim lijekovima moralo prekinuti;
There is insufficient data among different races with posaconazole concentrate for solution for infusion.
Nema dovoljno podataka o primjeni posakonazol koncentrata za otopinu za infuziju u različitim rasama.
Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1
Refraktorne invazivne gljivične infekcije/bolesnici s invazivnom gljivičnom infekcijom koji ne podnose lijekove iz prve linije liječenja
How to use Noxafil
Kako primjenjivati Noxafil
Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Noxafil oralna suspenzija indicirana je i za profilaksu invazivnih gljivičnih infekcija u sljedećih bolesnika: - u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromima (MDS) koji primaju kemoterapiju za postizanje remisije bolesti za koju se očekuje da će izazvati dugotrajnu neutropeniju i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija; - u primatelja transplantiranih hematopoetskih matičnih stanica koji primaju visoke doze imunosupresiva zbog reakcije presatka protiv primatelja i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija.
Posaconazole plasma concentrations following administration of posaconazole tablets are generally higher than those obtained with posaconazole oral suspension.
Koncentracije posakonazola u plazmi nakon primjene posakonazol tableta općenito su više nego pri primjeni posakonazol oralne suspenzije.
See “Other medicines and Noxafil” below for more information including information on other medicines which may interact with Noxafil.
Za informacije o drugim lijekovima koji mogu imati međusobno djelovanje s lijekom Noxafil, molimo pogledajte dio „Drugi lijekovi i Noxafil“
Gender The pharmacokinetics of posaconazole tablets are comparable in men and women.
Spol Farmakokinetika posakonazola tableta u žena usporediva je s onom u muškaraca.
How to store Noxafil
Kako čuvati Noxafil
Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections (Study 0041).
U ispitivanju liječenja invazivnih gljivičnih infekcija 16 bolesnika u dobi od 8-17 godina liječeno je posakonazol oralnom suspenzijom u dozi od 800 mg na dan (ispitivanje 0041).
• low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests - this can make you more likely to get infections
• nizak broj leukocita, vrste bijelih krvnih stanica (leukopenija), što se vidi na krvnim pretragama
Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Noxafil želučanootporne tablete indicirane su i za profilaksu invazivnih gljivičnih infekcija u sljedećih bolesnika: - u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromima (MDS) koji primaju kemoterapiju za postizanje remisije bolesti za koju se očekuje da će izazvati dugotrajnu neutropeniju i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija; - u primatelja transplantiranih hematopoetskih matičnih stanica koji primaju visoke doze imunosupresiva zbog reakcije presatka protiv primatelja i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija.
oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, infusion site pain, infusion site phlebitis, infusion site thrombosis, mucosal inflammation
edem, bol, zimica, opća slabost, nelagoda u prsištu, nepodnošenje lijeka, osjećaj treme, bol na mjestu infuzije, flebitis na mjestu infuzije, tromboza na mjestu infuzije, upala sluznica
Noxafil 300 mg sterile concentrate posaconazole
Noxafil 300 mg sterilni koncentrat posakonazol intravenska primjena nakon razrjeđivanja
• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.
• infekcija prouzročenih gljivicama Coccidioides koje se nisu poboljšale tijekom liječenja amfotericinom B, itrakonazolom ili flukonazolom ili kada se liječenje tim lijekovima moralo prekinuti.
Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Noxafil koncentrat za otopinu za infuziju indiciran je za liječenje sljedećih gljivičnih infekcija u odraslih osoba (vidjeti dio 5.1): - invazivne aspergiloze u bolesnika koji ne reagiraju na liječenje amfotericinom B ili itrakonazolom ili u bolesnika koji ne podnose ove lijekove; - fuzarioze u bolesnika koji ne reagiraju na liječenje amfotericinom B ili u bolesnika koji ne podnose amfotericin B; - kromoblastomikoze i micetoma u bolesnika koji ne reagiraju na liječenje itrakonazolom ili u bolesnika koji ne podnose itrakonazol; - kokcidioidomikoze u bolesnika koji ne reagiraju na liječenje amfotericinom B, itrakonazolom ili flukonazolom ili u bolesnika koji ne podnose ove lijekove.
Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products; - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.
Noxafil oralna suspenzija indicirana je za liječenje sljedećih gljivičnih infekcija u odraslih osoba (vidjeti dio 5.1): - invazivne aspergiloze u bolesnika koji ne reagiraju na liječenje amfotericinom B ili itrakonazolom ili u bolesnika koji ne podnose ove lijekove; - fuzarioze u bolesnika koji ne reagiraju na liječenje amfotericinom B ili u bolesnika koji ne podnose amfotericin B; - kromoblastomikoze i micetoma u bolesnika koji ne reagiraju na liječenje itrakonazolom ili u bolesnika koji ne podnose itrakonazol; - kokcidioidomikoze u bolesnika koji ne reagiraju na liječenje amfotericinom B, itrakonazolom ili flukonazolom ili u bolesnika koji ne podnose ove lijekove; - kandidijaze usta i ždrijela, kao prva linija liječenja bolesnika s teškim oblikom bolesti ili imunokompromitiranih bolesnika u kojih se očekuje slab odgovor na topikalnu terapiju.
Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Noxafil želučanootporne tablete indicirane su za liječenje sljedećih gljivičnih infekcija u odraslih osoba (vidjeti dio 5.1): - invazivne aspergiloze u bolesnika koji ne reagiraju na liječenje amfotericinom B ili itrakonazolom ili u bolesnika koji ne podnose ove lijekove; - fuzarioze u bolesnika koji ne reagiraju na liječenje amfotericinom B ili u bolesnika koji ne podnose amfotericin B; - kromoblastomikoze i micetoma u bolesnika koji ne reagiraju na liječenje itrakonazolom ili u bolesnika koji ne podnose itrakonazol; - kokcidioidomikoze u bolesnika koji ne reagiraju na liječenje amfotericinom B, itrakonazolom ili flukonazolom ili u bolesnika koji ne podnose ove lijekove;
You may need to have blood tests while you are taking
Dok uzimate Noxafil, možda ćete morati raditi pretrage krvi;
Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold), respectively.
Nakon istodobne primjene posakonazol oralne suspenzije (400 mg dvaput na dan) i atazanavira (300 mg jedanput na dan) tijekom 7 dana, u zdravih se ispitanika Cmax atazavira povećao prosječno 2,6 puta, a AUC 3,7 puta (raspon od 1,2 do 26 puta).
• rectal discomfort
• nelagoda u rektumu
Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
U farmakološkom ispitivanju sigurnosti ponovljenih doza u štakora, ehokardiografijom nisu utvrđeni znakovi dekompenzacije srca pri sustavnoj izloženosti 1,4 puta većoj od one koja se postiže tijekom liječenja.
Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole oral suspension (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
U 173 zdrava dobrovoljca muškog i ženskog spola u dobi od 18 do 85 godina prikupljeni su višekratni vremenski usklađeni nalazi EKG-a u razdoblju od 12 sati, i to prije i tijekom primjene posakonazol oralne suspenzije (400 mg dvaput na dan uz obroke bogate mastima).
Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.
Za primjenu kod kandidijaze usta i ždrijela molimo pogledajte Sažetak opisa svojstava lijeka za Noxafil oralnu suspenziju.
Posaconazole plasma concentrations following administration of posaconazole may increase over time in some patients (see section 5.2).
U nekih se bolesnika koncentracije posakonazola u plazmi nakon primjene posakonazola mogu s vremenom povećavati (vidjeti dio 5.2).
Repeat dose administration of oral posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Primjenom višestrukih doza posakonazol oralne suspenzije (400 mg dva puta na dan tijekom 16 dana) u zdravih se ispitanika Cmax sirolimusa (primijenjenog u jednokratnoj dozi od 2 mg) povećao za prosječno 6,7 puta, a AUC za prosječno 8,9 puta (raspon od 3,1 do 17,5 puta).
Clinical success rate at Day 14 Clinical success rate 4 weeks after end of treatment
Tablica 4. Postotak kliničkog uspjeha u liječenju kandidijaze usta i ždrijela Mjera ishoda
Hydrochloric acid [for pH adjustment] Sodium hydroxide [for pH adjustment] Water for injections
6.1 Popis pomoćnih tvari natrijev sulfobutileter β-ciklodekstrin (SBECD) dinatrijev edetat kloridna kiselina [za podešavanje pH] natrijev hidroksid [za podešavanje pH] voda za injekcije
• heart rhythm problems
• tegobe sa srčanim ritmom,
Each vial contains 300 mg of posaconazole.
Jedna bočica sadrži 300 mg posakonazola.
Fusarium spp.
Vrste roda Fusarium
• nausea or vomit (feeling or being sick), diarrhoea
• mučnina ili povraćanje, proljev
Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.2-fold greater than that achieved therapeutically.
U farmakološkom ispitivanju sigurnosti ponovljenih doza u štakora, ehokardiografijom nisu utvrđeni znakovi dekompenzacije srca pri sustavnoj izloženosti 2,2 puta većoj od one koja se postiže tijekom liječenja.
Investigations Uncommon:
Pretrage Manje često:
The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GvHD) only.
Formulacija u tableti ispitana je samo u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromom (MDS) te u bolesnika nakon transplantacije hematopoetskih matičnih stanica (HSCT) s reakcijom presatka protiv primatelja (engl. graft versus host disease, GVHD) ili rizikom od njena nastanka.
Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.1-fold greater than that achieved therapeutically.
U farmakološkom ispitivanju sigurnosti ponovljenih doza u štakora, ehokardiografijom nisu utvrđeni znakovi dekompenzacije srca pri sustavnoj izloženosti 2,1 puta većoj od one koja se postiže tijekom liječenja.
Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Nakon primjene posakonazol tableta u nekih bolesnika mogu se tijekom vremena povećati koncentracije posakonazola u plazmi.
- The active substance in Noxafil is posaconazole.
- Djelatna tvar u lijeku Noxafil je posakonazol.
• feeling weak, dizzy, tired or sleepy
• slabost, omaglica, umor ili pospanost
• pneumonia - signs include feeling short of breath and producing discoloured phlegm
• upala pluća - znakovi uključuju nedostatak zraka i promjenu boje iskašljaja
oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
edem, bol, zimica, opća slabost, nelagoda u prsištu, nepodnošenje lijeka, osjećaj treme, upala sluznica
The length of treatment may depend on the type of infection that you have or the length of time your immune system is not working properly and may be individually adapted for you by your doctor.
Vam imunološki sustav ne radi pravilno, a liječnik ga može individualno prilagoditi Vašim potrebama.
Gender The pharmacokinetics of posaconazole are comparable in men and women.
Spol Farmakokinetika posakonazola u žena usporediva je s onom u muškaraca.
Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the st day, 200 mg twice daily on the 2
Primjena višekratnih doza fosamprenavira (700 mg dvaput na dan tijekom 10 dana) s oralnom suspenzijom posakonazola (200 mg jedanput na dan prvog dana, 200 mg dvaput na dan drugog dana, a zatim 400 mg dvaput na dan sljedećih 8 dana) snizila je Cmax posakonazola za 21%, a AUC za 23%.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Noxafil.
Ako se nešto od gore navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego uzmete Noxafil.
- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.
Noxafil koncentrat za otopinu za infuziju indiciran je i za profilaksu invazivnih gljivičnih infekcija u sljedećih bolesnika: - u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromima (MDS) koji primaju kemoterapiju za postizanje remisije bolesti za koju se očekuje da će izazvati dugotrajnu neutropeniju i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija; - u primatelja transplantiranih hematopoetskih matičnih stanica (HSCT) koji primaju visoke doze imunosupresiva zbog reakcije presatka protiv primatelja (engl. graft-versus-host disease, GVHD) i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija.
Respiratory, thoracic and mediastinal disorders Uncommon:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često:
Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
U ispitivanju liječenja invazivnih gljivičnih infekcija 16 bolesnika u dobi od 8-17 godina liječeno je posakonazol oralnom suspenzijom u dozi od 800 mg na dan.
Glycerol
GVHD
If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.
Ako uzmete više lijeka Noxafil nego što ste trebali Ako mislite da ste uzeli previše lijeka Noxafil, odmah se obratite liječniku ili drugom zdravstvenom radniku.
• low potassium levels - shown up in blood tests
• niske razine kalija - vide se na krvnim pretragama
August 2021
kolovoz 2021.
Vascular occlusive events occurred in 44 of these 131 patients.
Događaji vaskularne okluzije javili su se u 44 od tih 131 bolesnika.
93055 Regensburg Germany
93055 Regensburg
The safety and efficacy of Iclusig in patients less than 18 years of age have not been established.
Sigurnost i djelotvornost u bolesnika mlađih od 18 godina još nije ustanovljena.
4879 AC Etten-Leur Netherlands
4879 AC Etten-Leur Nizozemska
1105 BP Amsterdam Netherlands
1105 BP Amsterdam Nizozemska
What you need to know before you take Iclusig Do not take Iclusig
Što morate znati prije nego počnete uzimati Iclusig
• if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section
• ako ste alergični na ponatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Date of latest renewal: 8 February 2018
Datum posljednje obnove odobrenja: 8. veljače 2018.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovog lijeka.
Tell your doctor straight away if you experience any of these symptoms during your treatment with ponatinib, because it could be serious.
Odmah obavijestite svog liječnika ukoliko primijetite bilo koji od ovih simptoma tijekom liječenja ponatinibom jer stanje može biti ozbiljno.
Efficacy results are summarized in Table 7, Table 8, and Table 9.
Rezultati djelotvornosti sažeti su u Tablici 7, Tablici 8 i Tablici 9.
Most patients who had an event of hepatotoxicity had their first event during the first year of treatment.
U većine bolesnika koji su imali događaj hepatotoksičnosti prvi je događaj zabilježen tijekom prve godine liječenja.
Baseline demographic characteristics are described in Table 6 below.
Početne demografske karakteristike opisane su u Tablici 6 u nastavku.
* Spontaneous reports from post-marketing experience
* Spontane prijave iz iskustva nakon stavljanja lijeka u promet
• recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
• ponovna pojava (ponovna aktivacija) infekcije virusom hepatitisa B ako ste u prošlosti imali hepatitis B (infekciju jetre)
Iclusig has minor influence on the ability to drive and use machines.
Iclusig ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.