FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Draxxin's benefits are greater than its risks and recommended that it be approved in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Draxxin nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: • Early stages of foot rot in sheep caused by Dichelobacter nodosus, which requires systemic treatment (treatment with a medicine given by mouth or by injection).
Croatian: • ranih faza truleži papaka u ovaca uzrokovane bakterijom Dichelobacter nodosus koja zahtijeva sustavnu terapiju (terapiju lijekom koji se daje na usta ili injekcijom).
English: Draxxin is effective against the bacteria that most commonly cause BRD, SRD, IBK and foot rot.
Croatian: Draxxin učinkovito djeluje protiv bakterija koje najčešće izazivaju BRD, SRD i IBK i trulež papaka.
English: Draxxin must not be used in animals that are producing milk for human consumption, or in pregnant animals intended to produce milk for human consumption within two months of their expected date of giving birth.
Croatian: Draxxin se ne smije koristiti u goveda koja daju mlijeko za ljudsku prehranu, niti u steonih krava koje daju mlijeko za ljudsku prehranu u razdoblju od dva mjeseca prije očekivanog datuma teljenja.
English: A single 2.5 mg/kg dose of Draxxin was effective in treating and preventing further outbreak of BRD in cattle and SRD in pigs.
Croatian: Jedna doza VMP-a Draxxin od 2,5 mg/kg pokazala se djelotvornom u liječenju i prevenciji novih pojava BRD-a u goveda i SRD-a u svinja.
English: In all studies, Draxxin was at least as effective as the comparator medicines.
Croatian: Draxxin je bio barem jednako učinkovit kao i usporedni lijekovi.
English: Temporary pain and swelling at the injection site in cattle can last up to 30 days after subcutaneous injection.
Croatian: Prolazna bol i oticanje na mjestu injekcije u goveda može trajati do 30 dana nakon injekcije pod kožu.
English: What are the risks associated with Draxxin?
Croatian: Koji su rizici povezani s VMP-om Draxxin?
English: How does Draxxin work?
Croatian: Kako djeluje Draxxin?
English: Draxxin can also be used for metaphylaxis of BRD and SRD.
Croatian: Draxxin se također može koristiti kao metafilaksa BRD-a i SRD-a.
English: For effectiveness in treating foot rot in sheep, Draxxin was compared to tilmicosin in a study involving 477 sheep with typical signs of foot rot (foul smell, damaged tissue between the claws of at least one foot and lameness).
Croatian: Kako bi se ispitala njegova djelotvornost u liječenju truleži papaka u ovaca, Draxxin je uspoređen s tilmikozinom u ispitivanju kojim je bilo obuhvaćeno 477 ovaca s tipičnim znakovima truleži papaka (smrad, oštećenje tkiva interdigitalnog prostora na barem jednom papku i šepavost).
English: In two studies, it was compared with placebo, and the third study also compared it with oxytetracycline (another antibiotic).
Croatian: U dvama ispitivanjima uspoređen je s placebom, a u trećem ispitivanju uspoređen je s oksitetraciklinom (drugim antibiotikom).
English: Other types of reaction to the injection persist for about 30 days after injection in cattle and pigs.
Croatian: Druge vrste reakcija na injekciju u goveda i svinja traju oko 30 dana nakon injekcije.
English: In cattle, it is injected under the skin, and the dose is divided in cattle weighing over 300 kg so that no more than 7.5 ml are injected at one site.
Croatian: U goveda se ubrizgava pod kožu, pri čemu se u goveda težih od 300 kg doza dijeli tako da se na jedno mjesto ubrizgava najviše 7,5 ml.
English: The effectiveness of Draxxin in treating SRD has been studied in pigs in two main studies, where it was compared with the antibiotics tiamulin or florfenicol.
Croatian: Djelotvornost VMP-a Draxxin u liječenju SRD-a ispitivana je na svinjama u dvama glavnim ispitivanjima, pri čemu je uspoređen s antibioticima tiamulinom ili florfenikolom.
English: In pigs it is injected into a muscle, and the dose is divided in pigs weighing over 80 kg so that no more than 2 ml are injected at one site.
Croatian: U svinja se ubrizgava u mišić, pri čemu se u svinja težih od 80 kg doza dijeli tako da se na jedno mjesto ubrizgava najviše 2 ml.
English: In two of the three studies of IBK, Draxxin was more effective than placebo in curing the disease.
Croatian: U dvama od tri ispitivanja za liječenje IBK-a Draxxin je bio djelotvorniji od placeba.
English: Draxxin was as effective as tilmicosin in treating the early stages of severe foot rot.
Croatian: Draxxin se pokazao jednako djelotvornim kao tilmikozin u liječenju teške truleži papaka u ranoj fazi.
English: Draxxin is an antibiotic medicine that contains the active substance tulathromycin.
Croatian: Draxxin je antibiotički VMP koji sadrži djelatnu tvar tulatromicin.
English: The effectiveness of Draxxin in treating or preventing BRD was studied in nine main studies involving calves, carried out during an outbreak of the disease.
Croatian: Djelotvornost VMP-a Draxxin u liječenju ili sprječavanju BRD-a ispitana je u devet glavnih ispitivanja na teladi koja su provedena ubrzo nakon izbijanja bolesti.
English: It is also the time required after administration of a medicine before milk can be used for human consumption.
Croatian: To je također vrijeme koje treba proći nakon primjene VMP-a prije nego što ljudi smiju konzumirati mlijeko dotične životinje.
English: • infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis;
Croatian: • zaraznog keratokonjunktivitisa goveda (IBK), bolesti oka u goveda uzrokovane bakterijom
English: Treatment with Draxxin was compared to another antibiotic, tildipirosin.
Croatian: Terapija VMP-om Draxxin uspoređena je s drugim antibiotikom, tildipirozinom.
English: For the metaphylaxis of SRD, the effectiveness of Draxxin was studied in six main studies, in which it was compared with placebo.
Croatian: Za metafilaksu SRD-a, djelotvornost VMP-a Draxxin ispitana je u šest glavnih ispitivanja u kojima je uspoređen s placebom.
English: What benefits of Draxxin have been shown in studies?
Croatian: Koje su koristi lijeka Draxxin utvrđene u ispitivanjima?
English: The active substance in Draxxin, tulathromycin, is an antibiotic that belongs to the class ‘macrolides'.
Croatian: Djelatna tvar VMP-a Draxxin, tulatromicin, antibiotik je koji pripada razredu „makrolida”.
English: For practical information about using Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Draxxin vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For more information about treatment with Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Draxxin vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For the treatment of IBK, the effectiveness of Draxxin has been studied in three main studies involving calves.
Croatian: Za liječenje IBK-a, djelotvornost VMP-a Draxxin ispitana je u tri glavna ispitivanja na teladi.
English: • bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis;
Croatian: Pasteurella multocida, Histophilus somni i Mycoplasma bovis;
English: SRD with Bordetella bronchiseptica present.
Croatian: Trećim ispitivanjem bile su obuhvaćene svinje sa SRD-om uz prisutnost bakterije Bordetella bronchiseptica.
English: EU number
Croatian: Broj EU
English: 30 x 1 tablets (unit dose)
Croatian: 30 × 1 tableta (jedinična doza)
English: Immediate Packaging
Croatian: Unutarnje pakiranje Veličina pakiranja
English: Do not add more food.
Croatian: Nemojte dodavati više hrane.
English: 3 Choose a soft food the child likes.
Croatian: 3 Odaberite mekanu hranu koju dijete voli.
English: At the request of the European Medicines Agency;
Croatian: • na zahtjev Europske agencije za lijekove;
English: Some patients have actually committed suicide.
Croatian: Neki bolesnici su počinili samoubojstvo.
English: Tell your doctor:
Croatian: Obavijestite svog liječnika:
English: For blisters: 2 years.
Croatian: Za blistere: 2 godine.
English: Children and adolescents (3 months to 17 years)
Croatian: Djeca i adolescenti (3 mjeseca do 17 godina)
English: Your doctor will test for these changes.
Croatian: Vaš liječnik će obaviti provjeru tih promjena.
English: Risk to the infant can not be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Date of latest renewal: 23 April 2014
Croatian: Datum posljednje obnove odobrenja: 23. travanj 2014.
English: any signs of inflammation or infection.
Croatian: bilo kakve znakove upale ili infekcije.
English: 9 If the daily dose consists of more than one capsule, follow steps 5-8 for each capsule.
Croatian: Ako se dnevna doza sastoji od više od jedne kapsule, slijedite korake 5 - 8 za svaku kapsulu.
English: Control regimen (n=635)
Croatian: kontrolni režim (n=635)
English: What SUSTIVA is and what it is used for 2.
Croatian: Što je SUSTIVA i za što se koristi 2.
English: Gender, race, elderly
Croatian: Spol, rasa, stariji bolesnici
English: Your doctor will give you instructions for proper dosing.
Croatian: Liječnik će Vam dati upute o pravilnom doziranju.
English: The virus may then become harder to treat.
Croatian: Tada virus može postati otporniji na liječenje.
English: Other interactions
Croatian: Ostale interakcije
English: Tell your doctor immediately if you are pregnant or intend to become pregnant.
Croatian: Odmah obavijestite svog liječnika ako ste trudni ili planirate zatrudnjeti.
English: 48 weeks
Croatian: 48 tjedana
English: Component of a multipack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se zasebno prodavati.
English: 2 Wash and dry your hands before and after preparing the capsule sprinkle.
Croatian: 2 Operite i osušite ruke prije i nakon pripreme posipanja sadržaja kapsule.
English: Effect of food
Croatian: Utjecaj hrane
English: 24 weeks
Croatian: 24 tjedna
English: The dose for children and adolescents is calculated by body weight and is taken once daily as shown below:
Croatian: Doza lijeka za djecu i adolescente računa se prema tjelesnoj težini i uzima se jedanput na dan, kako je prikazano ispod:
English: Use a small container for mixing.
Croatian: Koristite malu posudu za miješanje.
English: Try not to miss a dose.
Croatian: Pokušajte ne propustiti dozu lijeka.
English: If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Croatian: Ako ipak propustite uzeti dozu, sljedeću dozu uzmite što je prije moguće, ali nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu.
English: Keep the medicine container with you so that you can easily describe what you have taken.
Croatian: Ponesite sa sobom bočicu lijeka da lakše možete opisati što ste uzeli.
English: In controlled trials, the frequency of specific serious psychiatric events were:
Croatian: U kontroliranim ispitivanjima učestalost specifičnih ozbiljnih psihijatrijskih događaja bila je sljedeća:
English: Study ACTG 364 48 weeks
Croatian: Ispitivanje ACTG 364 48 tjedana
English: a 90% confidence intervals unless otherwise noted.
Croatian: a 90% interval pouzdanosti, osim ako nije drugačije navedeno.
English: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL United Kingdom
Croatian: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL Velika Britanija
English: If available, 90% or 95% confidence intervals are shown in parentheses.
Croatian: Ako su dostupni, podaci o intervalima pouzdanosti od 90% ili 95% navedeni su u zagradama.
English: Studies were conducted in healthy subjects unless otherwise noted.
Croatian: Ispitivanja su provedena u zdravih ispitanika, osim ako nije drugačije navedeno.
English: b 95% confidence intervals.
Croatian: b 95% interval pouzdanosti.
English: What SUSTIVA is and what it is used for
Croatian: Što je SUSTIVA i za što se koristi
English: 5 SUSTIVA capsules must be opened carefully over the food container, as described in steps 6-7, so that the contents do not spill.
Croatian: 5 SUSTIVA kapsule moraju se pažljivo otvoriti iznad posude s hranom, kako je opisano u koracima 6 - 7, tako da se sadržaj ne prospe.
English: Adults and adolescents over 40 kg
Croatian: Odrasli i adolescenti tjelesne mase iznad 40 kg
English: Eighty-seven percent of patients had received prior antiretroviral therapy.
Croatian: Osamdeset sedam posto bolesnika prethodno je primilo antiretrovirusnu terapiju.
English: 1 Avoid giving the daily SUSTIVA dose within 1 hour after a feeding or meal.
Croatian: 1 Izbjegavajte davanje dnevne doze lijeka SUSTIVA unutar 1 sata nakon hranjenja ili jela.
English: Long-term use of efavirenz in this study was not associated with any new safety concerns.
Croatian: Dugotrajna primjena efavirenza u ovom ispitivanju nije bila povezana s novim sigurnosnim pitanjima.
English: if you have a history of liver disease, including active chronic hepatitis.
Croatian: ako ste imali bolest jetre, uključujući aktivni kronični hepatitis.
English: The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Croatian: Doza metadona povećana je za prosječno 22% kako bi se ublažili simptomi ustezanja.
English: Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study.
Croatian: Slične su rezultate dobili i drugi ispitivači, premda su razine MPA u plazmi u drugom ispitivanju bile varijabilnije.
English: Efavirenz has been studied in over 9,000 patients.
Croatian: Efavirenz je ispitan na više od 9000 bolesnika.
English: If you are pregnant, you should take SUSTIVA only if you and your doctor decide it is clearly needed.
Croatian: Ako ste trudni, lijek SUSTIVA smijete uzimati samo ako ste zajedno s liječnikom odlučili da je to neophodno.
English: ATC code: J05AG03
Croatian: ATK oznaka: J05AG03
English: One patient experienced involuntary muscle contractions.
Croatian: Jedan je bolesnik imao nevoljne mišićne kontrakcije.
English: What SUSTIVA contains
Croatian: Što SUSTIVA sadrži
English: Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Croatian: Neki bolesnici imaju ozbiljnije simptome koji mogu utjecati na raspoloženje ili sposobnost rasuđivanja.
English: 30 x 1 TABLETS
Croatian: 30 X 1 TABLETA
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Smatra se da su ti simptomi posljedica poboljšanja imunološkog odgovora koji omogućava tijelu da se bori protiv infekcija koje su možda bile prisutne bez vidljivih simptoma.
English: Not recommended as the exposure to both PIs is expected to be significantly decreased.
Croatian: Ne preporučuje se jer se za oba IP-a očekuje značajno smanjena izloženost.
English: The clinical significance of these effects is not known.
Croatian: Nije poznat klinički značaj ovih učinaka.
English: The child should not be given any additional food for 2 hours.
Croatian: Dijete ne smije uzimati nikakvu dodatnu hranu u naredna 2 sata.
English: SUSTIVA must be taken every day.
Croatian: Lijek SUSTIVA morate uzimati svaki dan.
English: Dose reduction or splitting the daily dose has not been shown to provide benefit.
Croatian: Smanjenje doze ili dijeljenje dnevne doze na više doza nije se pokazalo korisnim.
English: This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir.
Croatian: Ovo sniženje Cmin atazanavira može negativno utjecati na djelotvornost atazanavira.
English: ---, not performed.
Croatian: ---, nije analizirano.
English: 6.5 Nature and content of container
Croatian: 6.5 Vrsta i sadržaj spremnika
English: UNIQUE IDENTIFIED - 2D BARCODE Outer carton: 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Kutija: Sadrži 2D barkod s jedinstvenim identifikatorom.
English: b C.I., confidence interval.
Croatian: C.I., interval pouzdanosti.
English: SUSTIVA with food and drink
Croatian: SUSTIVA s hranom i pićem
English: Other interactions: efavirenz does not bind to cannabinoid receptors.
Croatian: Druge interakcije: efavirenz se ne veže za kanabinoidne receptore.
English: The dose for SUSTIVA may need to be increased or decreased if you are also taking certain medicines (see Other medicines and SUSTIVA).
Croatian: Dozu lijeka SUSTIVA možda će trebati povisiti ili sniziti ako uzimate i neke druge lijekove (pogledajte Drugi lijekovi i SUSTIVA).
English: Metabolic parameters
Croatian: Metabolički parametri
English: Caution is warranted since this dose adjustment might be insufficient in some patients.
Croatian: Potreban je oprez, jer ovako prilagođena doza može biti nedovoljna za neke bolesnike.
English: You must not take SUSTIVA with certain medicines.
Croatian: Ne smijete uzimati lijek SUSTIVA s određenim lijekovima.
English: Steps 11-14 must be completed within 30 minutes of mixing: 11 Give the mixture of food and capsule contents to the child, making sure he or she eats the full amount (illustration f).
Croatian: Koraci 11 - 14 moraju se dovršiti najkasnije 30 minuta nakon miješanja: 11 Dajte djetetu mješavinu hrane i sadržaja kapsule, pazeći da ono pojede svu količinu (ilustracija f).
English: This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
Croatian: To će Vam ojačati imunološki sustav i smanjiti rizik od razvoja bolesti povezanih s HIV-infekcijom.
English: The antiretroviral medicinal products should be restarted at the same time upon resolution of the intolerance symptoms.
Croatian: Antiretrovirusni lijekovi se moraju ponovno početi uzimati u isto vrijeme po povlačenju simptoma intolerancije.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
Croatian: Bolesnike treba uputiti da, ako se u njih pojave navedeni simptomi, moraju izbjegavati obavljanje potencijalno opasnih radnji kao što su vožnja ili rad sa strojevima.
English: Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Croatian: Pojedini bolesnici koji su slučajno uzeli dozu od 600 mg dvaput na dan prijavili su pojačanje simptoma živčanog sustava.
English: Make sure the child eats the full amount of the mixture of food and capsule contents.
Croatian: Uvjerite se da je dijete pojelo cijelu mješavinu hrane i sadržaja kapsule.
English: Skin and subcutaneous tissue disorders very common rash (11.6%)*
Croatian: Poremećaji kože i potkožnog tkiva vrlo često osip (11,6%)*
English: - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Croatian: - teške poremećaje ravnoteže elektrolita, npr. hipokalijemiju ili hipomagnezemiju.
English: Patients should be monitored for seizure control.
Croatian: Bolesnike se mora nadzirati radi kontrole napadaja.
English: rare photoallergic dermatitis
Croatian: rijetko fotoalergijski dermatitis†
English: Very common (affects more than 1 user in 10) skin rash
Croatian: Vrlo često (javljaju se u više od 1 na 10 korisnika) kožni osip
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Croatian: Preporučuje se da žene zaražene HIV-om ni u kojem slučaju ne doje svoju djecu kako bi izbjegle prenošenje HIV-a.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Croatian: Za lipide, u nekim slučajevima postoji dokaz o učinku liječenja, dok za debljanje nema čvrstog dokaza povezanog s bilo kojim posebnim liječenjem.
English: Biliary fibrosis has been observed in rats.
Croatian: U štakora je zapažena bilijarna fibroza.
English: The doctor may also recommend this method of taking SUSTIVA for adults who cannot swallow capsules.
Croatian: Liječnik također može preporučiti primjenu ove metode uzimanja lijeka SUSTIVA kod odraslih osoba koje ne mogu progutati kapsulu.
English: Treatment of overdose with efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status.
Croatian: Liječenje predoziranja efavirenzom mora obuhvatiti opće potporne mjere, uključujući nadzor vitalnih znakova i praćenje kliničkog statusa bolesnika.
English: Consider doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week in combination with efavirenz.
Croatian: Treba razmotriti udvostručenje doze rifabutina u režimima u kojima se rifabutin primjenjuje 2 ili 3 puta tjedno u kombinaciji s efavirenzom.
English: Other medicines and SUSTIVA
Croatian: Drugi lijekovi i SUSTIVA
English: While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
Croatian: Premda nije poznat kancerogeni potencijal u ljudi, ovi podaci pokazuju da je klinička korist primjene efavirenza veća od potencijalnog kancerogenog rizika za ljude.
English: Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with SUSTIVA.
Croatian: Vaš liječnik će možda zatražiti da napravite test na trudnoću kako biste bili sigurni da niste trudni prije nego što počnete liječenje lijekom SUSTIVA.
English: Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Croatian: Odmah obavijestite liječnika ako se osjećate deprimirano, razmišljate o samoubojstvu ili imate neuobičajene misli (pogledajte dio 4. Moguće nuspojave).
English: - severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
Croatian: - teška depresija - suicidalne misli - pokušaji samoubojstva bez smrtnog ishoda - agresivno ponašanje - paranoidne reakcije - manične reakcije
English: Your doctor has prescribed SUSTIVA for you because you have HIV infection.
Croatian: Liječnik Vam je propisao lijek SUSTIVA jer ste zaraženi HIV-om.
English: Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.
Croatian: Dozu bupropiona treba povećavati u skladu s kliničkim odgovorom, ali se ne smije prekoračiti maksimalna preporučena doza bupropiona.
English: Confirmatory testing by a more specific method such as gas chromatography/mass spectrometry is recommended in such cases.
Croatian: U takvim slučajevima preporučuje se potvrdni test sa specifičnijim metodama poput plinske kromatografije/masene spektrometrije.
English: Number of Capsules or Tablets and Strength to Administer kg
Croatian: Broj kapsula ili tableta i jačina za primjenu
English: Treatment Regimend n
Croatian: Režim liječenja n
English: Substantial decrease in lopinavir exposure.
Croatian: Znatno snižena izloženost lopinaviru.
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Croatian: Incidencija multiformnog eritema ili Stevens-Johnsonovog sindroma bila je približno 0,1%.
English: An empty stomach is commonly defined as 1 hour before or 2 hours after a meal.
Croatian: Prazan želudac obično znači 1 sat prije ili 2 sata nakon obroka.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki simptom upale mora se procijeniti i po potrebi započeti liječenje.
English: Patients with severe hepatic impairment (Child Pugh Class C) (see section 5.2).
Croatian: Bolesnici s teškim oštećenjem jetre (Child Pugh stadij C) (vidjeti dio 5.2).